Flexible pneumostoma management system and methods for treatment of chronic obstructive pulmonary disease

ABSTRACT

A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The pneumostoma management device includes a pneumostoma vent having a tube which enters the pneumostoma to allow gases to escape the lung, a flange and a filter/valve to control flow of materials through the tube. The flange is a thin flexible patch which conforms and attaches to the chest of the patient. The flange secures the tube in position in the pneumostoma.

CLAIM TO PRIORITY

This application claims priority to all of the following applicationsincluding: U.S. Provisional Application No. 61/029,830, filed Feb. 19,2008, entitled “ENHANCED PNEUMOSTOMA MANAGEMENT DEVICE AND METHODS FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06013US0);

U.S. Provisional Application No. 61/032,877, filed Feb. 29, 2008,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06001US0);

U.S. Provisional Application No. 61/038,371, filed Mar. 20, 2008,entitled “SURGICAL PROCEDURE AND INSTRUMENT TO CREATE A PNEUMOSTOMA ANDTREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06000US0);

U.S. Provisional Application No. 61/082,892, filed Jul. 23, 2008,entitled “PNEUMOSTOMA MANAGEMENT SYSTEM HAVING A COSMETIC AND/ORPROTECTIVE COVER” (Attorney Docket No. LUNG1-06008US0);

U.S. Provisional Application No. 61/083,573, filed Jul. 25, 2008,entitled “DEVICES AND METHODS FOR DELIVERY OF A THERAPEUTIC AGENTTHROUGH A PNEUMOSTOMA” (Attorney Docket No. LUNG1-06003US0);

U.S. Provisional Application No. 61/084,559, filed Jul. 29, 2008,entitled “ASPIRATOR FOR PNEUMOSTOMA MANAGEMENT” (Attorney Docket No.LUNG1-06011US0);

This application is a continuation of U.S. patent application Ser. No.12/388,458, filed Feb. 18, 2009 entitled “FLEXIBLE PNEUMOSTOMAMANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVEPULMONARY DISEASE” and claims the benefit of priority to U.S.Provisional Application No. 61/088,118, filed Aug. 12, 2008, entitled“FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06004US0);

U.S. Provisional Application No. 61/143,298, filed Jan. 8, 2009,entitled “METHODS AND APPARATUS FOR THE CRYOTHERAPY CREATION ORRE-CREATION OF PNEUMOSTOMY” (Attorney Docket No. LUNG1-06006US0); and

U.S. Provisional Application No. 61/151,581, filed Feb. 11, 2009,entitled “SURGICAL INSTRUMENTS AND PROCEDURES TO CREATE A PNEUMOSTOMAAND TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06002U50).

All of the afore-mentioned applications are incorporated herein byreference in their entireties.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to all of the above provisional applicationsand all the patent applications that claim priority thereto including:

This application is related to all of the following applicationsincluding U.S. patent application Ser. No. ______, filed Feb. 18, 2009,entitled “ENHANCED PNEUMOSTOMA MANAGEMENT DEVICE AND METHODS FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06013US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONICOBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF CHRONIC OBSTRUCTIVEPULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US2);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“TWO-PHASE SURGICAL PROCEDURE FOR CREATING A PNEUMOSTOMA TO TREATCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06000US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“ACCELERATED TWO-PHASE SURGICAL PROCEDURE FOR CREATING A PNEUMOSTOMA TOTREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06000US2);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“SINGLE-PHASE SURGICAL PROCEDURE FOR CREATING A PNEUMOSTOMA TO TREATCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06000US3);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“PERCUTANEOUS SINGLE-PHASE SURGICAL PROCEDURE FOR CREATING A PNEUMSOTOMATO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06000US4);

U.S. patent application Ser. No. ______, filed Feb. 13, 2009, entitled“PNEUMOSTOMA MANAGEMENT SYSTEM HAVING A COSTMETIC AND/OR PROTECTIVECOVER” (Attorney Docket No. LUNG1-06008US1)

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“DEVICES AND METHODS FOR DELIVERY OF A THERAPEUTIC AGENT THROUGH APNEUMOSTOMA” (Attorney Docket No. LUNG1-06003US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“ASPIRATOR FOR PNEUMOSTOMA MANAGEMENT” (Attorney Docket No.LUNG1-06011US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“ASPIRATOR AND METHOD FOR PNEUMOSTOMA MANAGEMENT” (Attorney Docket No.LUNG1-06011US2);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“METHODS AND DEVICES FOR FOLLOW-UP CARE AND TREATMENT OF A PNEUMOSTOMA”(Attorney Docket No. LUNG1-06006US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“SURGICAL INSTRUMENTS FOR CREATING A PNEUMOSTOMA AND TREATING CHRONICOBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06002US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“ONE-PIECE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06017US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“PNEUMOSTOMA MANAGEMENT SYSTEM WITH SECRETION MANAGEMENT FEATURES FORTREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06019US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“MULTI-LAYER PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OFCHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No.LUNG1-06022US1);

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“VARIABLE LENGTH PNEUMOSTOMA MANAGEMENT SYSTEM FOR TREATMENT OF CHRONICOBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06023US1); and

U.S. patent application Ser. No. ______, filed Feb. 18, 2009, entitled“SELF-SEALING DEVICE AND METHOD FOR DELIVERY OF A THERAPEUTIC AGENTTHROUGH A PNEUMOSTOMA” (Attorney Docket No. LUNG1-06025US1).

All of the afore-mentioned applications are incorporated herein byreference in their entireties. This patent application also incorporatesby reference all patents, applications, and articles discussed and/orcited herein.

BACKGROUND OF THE INVENTION

In the United States alone, approximately 14 million people suffer fromsome form of Chronic Obstructive Pulmonary Disease (COPD). However, anadditional ten million adults have evidence of impaired lung functionindicating that COPD may be significantly underdiagnosed. The cost ofCOPD to the nation in 2002 was estimated to be $32.1 billion. Medicareexpenses for COPD beneficiaries were nearly 2.5 times that of theexpenditures for all other patients. Direct medical services accountedfor $18.0 billion, and indirect cost of morbidity and prematuremortality was $14.1 billion. COPD is the fourth leading cause of deathin the U.S. and is projected to be the third leading cause of death forboth males and females by the year 2020.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease ofthe airways that is characterized by a gradual loss of lung function. Inthe United States, the term COPD includes chronic bronchitis, chronicobstructive bronchitis, and emphysema, or combinations of theseconditions. In emphysema the alveoli walls of the lung tissue areprogressively weakened and lose their elastic recoil. The breakdown oflung tissue causes progressive loss of elastic recoil and the loss ofradial support of the airways which traps residual air in the lung. Thisincreases the work of exhaling and leads to hyperinflation of the lung.When the lungs become hyperinflated, forced expiration cannot reduce theresidual volume of the lungs because the force exerted to empty thelungs collapses the small airways and blocks air from being exhaled. Asthe disease progresses, the inspiratory capacity and air exchangesurface area of the lungs is reduced until air exchange becomesseriously impaired and the individual can only take short shallowlabored breaths (dyspnea).

The symptoms of COPD can range from the chronic cough and sputumproduction of chronic bronchitis to the severe disabling shortness ofbreath of emphysema. In some individuals, chronic cough and sputumproduction are the first signs that they are at risk for developing theairflow obstruction and shortness of breath characteristic of COPD. Withcontinued exposure to cigarettes or noxious particles, the diseaseprogresses and individuals with COPD increasingly lose their ability tobreathe. Acute infections or certain weather conditions may temporarilyworsen symptoms (exacerbations), occasionally where hospitalization maybe required. In others, shortness of breath may be the first indicationof the disease. The diagnosis of COPD is confirmed by the presence ofairway obstruction on testing with spirometry. Ultimately, severeemphysema may lead to severe dyspnea, severe limitation of dailyactivities, illness and death.

There is no cure for COPD or pulmonary emphysema, only varioustreatments, for ameliorating the symptoms. The goal of currenttreatments is to help people live with the disease more comfortably andto prevent the progression of the disease. The current options include:self-care (e.g., quitting smoking), medications (such as bronchodilatorswhich do not address emphysema physiology), long-term oxygen therapy,and surgery (lung transplantation and lung volume reduction surgery).Lung Volume Reduction Surgery (LVRS) is an invasive procedure primarilyfor patients who have a localized (heterogeneous) version of emphysema;in which, the most diseased area of the lung is surgically removed toallow the remaining tissue to work more efficiently. Patients withdiffuse emphysema cannot be treated with LVRS, and typically only havelung transplantation as an end-stage option. However, many patients arenot candidates for such a taxing procedure.

A number of less-invasive surgical methods have been proposed forameliorating the symptoms of COPD. In one approach new windows areopened inside the lung to allow air to more easily escape from thediseased tissue into the natural airways. These windows are kept openwith permanently implanted stents. Other approaches attempt to seal offand shrink portions of the hyperinflated lung using chemical treatmentsand/or implantable plugs. However, these proposals remain significantlyinvasive and are still in clinical trails. None of the surgicalapproaches to treatment of COPD has been widely adopted. Therefore, alarge unmet need remains for a medical procedure that can sufficientlyalleviate the debilitating effects of COPD and emphysema.

SUMMARY OF THE INVENTION

In view of the disadvantages of the state of the art, Applicants havedeveloped a method for treating COPD in which an artificial passagewayis made through the chest wall into the lung. An anastomosis is formedbetween the artificial passageway and the lung by creating a pleurodesisbetween the visceral and parietal membranes surrounding the passagewayas it enters the lung. The pleurodesis prevents air from entering thepleural cavity and causing a pneumothorax (deflation of the lung due toair pressure in the pleural cavity). The pleurodesis is stabilized by afibrotic healing response between the membranes. The artificialpassageway through the chest wall also becomes epithelialized. Theresult is a stable artificial aperture through the chest wall whichcommunicates with the parenchymal tissue of the lung.

The aperture into the lung through the chest wall is referred to hereinas a pneumostoma. A pneumostoma provides an extra pathway that allowsair to exit the lung while bypassing the natural airways which have beenimpaired by COPD and emphysema. By providing this ventilation bypass,the pneumostoma allows the stale air trapped in the lung to escape fromthe lung thereby shrinking the lung (reducing hyperinflation). Byshrinking the lung, the ventilation bypass reduces breathing effort(reducing dyspnea), allows more fresh air to be drawn in through thenatural airways and increases the effectiveness of all of the tissues ofthe lung for gas exchange. Increasing the effectiveness of gas exchangeallows for increased absorption of oxygen into the bloodstream and alsoincreased removal of carbon dioxide. Reducing the amount of carbondioxide retained in the lung reduces hypercapnia which also reducesdyspnea. The pneumostoma thereby achieves the advantages of lung volumereduction surgery without surgically removing a portion of the lung orsealing off a portion of the lung.

Procedures, techniques and tools for creating a pneumostoma aredescribed in applicants' copending application entitled “SurgicalProcedure And Instrument To Create A Pneumostoma And Treat ChronicObstructive Pulmonary Disease” to Tanaka (Provisional Ser. No.61/038,371 Filed Mar. 20, 2008). Additional devices for managing apneumostoma are described in applicants' copending patent applicationtitled “Pneumostoma Management System And Methods For Treatment OfChronic Obstructive Pulmonary Disease” to Tanaka (Provisional Ser. No.61/032,877 filed Feb. 29, 2008). These patent applications, and allother patents and patent applications referred to herein, areincorporated by reference in their entirety.

In accordance with one embodiment, the present invention provides apneumostoma management system which includes a pneumostoma managementdevice having a temporarily implantable pneumostoma vent. Thetemporarily implantable pneumostoma vent is placed into a pneumostoma tomaintain the patency of the pneumostoma, prevent the entry of foreignsubstances into the lung, control air flow through the pneumostoma andcollect any materials that may exit the lung.

In accordance with one embodiment, the present invention provides atwo-piece pneumostoma management system which includes apartially-implantable pneumostoma vent and a chest mount. Thepartially-implantable pneumostoma vent is placed into a pneumostomathrough an aperture in the chest mount. The partially-implantablepneumostoma management device is designed such that every component islarger than the aperture in the chest mount and thus cannot enter thepneumostoma.

In accordance with another embodiment of the present invention, a methodis provided for using the disclosed pneumostoma management systems tomaintain the patency of the pneumostoma, prevent the entry of foreignsubstances into the lung, control air flow through a pneumostoma andcontrol any materials that may exit the lung.

In accordance with particular embodiments, the present inventionprovides a flexible pneumostoma management system for maintaining thepatency of a pneumostoma while controlling the flow of material throughthe pneumostoma. The pneumostoma management system includes apneumostoma vent having a thin flexible flange which attaches to thechest and conforms to the skin of the patient. The pneumostoma ventincludes a filter. In some embodiments a thin flexible chest mount ispositioned between the flange and the chest of the patient.

In accordance with a specific embodiment, the present invention providesa pneumostoma management system having: a tube adapted for insertioninto the chest through the pneumostoma, the tube having a lumen, aproximal end and a distal end, the distal end of the tube having anatraumatic tip, the distal end of the tube having at least one openingadapted to admit gases from the lung; and a flange connected to theproximal end of the tube such that an opening in the flange connects tothe lumen of the tube, the flange projecting a sufficient distance fromthe tube to preclude passage of flange into the pneumostoma, the flangebeing sufficiently thin and flexible to conform to the chest of thepatient, the flange having an adhesive coating for releasably securingthe flange to the chest of the patient; and a filter disposed over theopening in the flange and secured to one of the flange and tube suchthat gases passing into and out of the lumen of the tube pass throughthe filter.

Thus, various systems, components and methods are provided for managinga pneumostoma and thereby treating COPD. Other objects, features andadvantages of the invention will be apparent from drawings and detaileddescription to follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further features, advantages and benefits of the presentinvention will be apparent upon consideration of the present descriptiontaken in conjunction with the accompanying drawings.

FIG. 1A shows the chest of a patient indicating alternative locationsfor a pneumostoma that may be managed using the device and methods ofthe present invention.

FIG. 1B shows a sectional view of the chest illustrating therelationship between the pneumostoma, lung and natural airways.

FIG. 1C shows a detailed sectional view of a pneumostoma.

FIG. 2A shows a perspective view of components of a pneumostomamanagement system according to an embodiment of the present invention.

FIG. 2B shows a sectional view of the components of FIG. 2A.

FIG. 2C shows an alternative pneumostoma vent.

FIGS. 3A-3C show an alternative pneumostoma management device accordingto an embodiment of the present invention.

FIGS. 4A-4F show alternative pneumostoma management devices according toembodiments of the present invention.

FIGS. 5A-5C show alternative pneumostoma management devices according toembodiments of the present invention.

FIGS. 6A-6F show alternative pneumostoma management devices according toembodiments of the present invention.

FIGS. 6G-6J show alternative filter arrangements for pneumostomamanagement devices according to embodiments of the invention.

FIGS. 7A and 7B show instructions for using a pneumostoma managementsystem in accordance with an embodiment of the present invention.

FIGS. 8A-8D show plugs for pneumostoma management devices according toembodiments of the present invention.

FIGS. 9A-9H show alternative pneumostoma vent and chest mountconfigurations for pneumostoma management systems according toembodiments of the present invention.

FIGS. 10A-10D show alternative adhesive patterns for attachment ofpneumostoma vents according to embodiments of the present invention.

FIGS. 10E-10G show views of an alternative pneumostoma vent according toand embodiment of the present invention.

FIGS. 10H-10J show views of alternative pneumostoma vents according toembodiments of the present invention.

FIGS. 11A-11D show views alternative pneumostoma vents according to apreferred embodiments of the present invention.

FIGS. 11E-11H show steps in the manufacture of a pneumostoma vent tubeaccording to an embodiment of the present invention.

FIGS. 11I and 11J show packaging options for a preferred pneumostomavent system according to an embodiment of the present invention.

FIGS. 11K-11M show steps in the deployment of a preferred pneumostomavent system as packaged in FIG. 11J according to an embodiment of thepresent invention.

FIG. 11N shows a preferred embodiment of a pneumostoma vent tube for apneumostoma vent.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best modes presently contemplatedfor practicing various embodiments of the present invention. Thedescription is not to be taken in a limiting sense but is made merelyfor the purpose of describing the general principles of the invention.It is to be understood that features described in reference to aparticular embodiments may be combined with features of other particularembodiments. The scope of the invention should be ascertained withreference to the claims. In the description of the invention thatfollows, like numerals or reference designators will be used to refer tolike parts or elements throughout. In addition, the first digit of areference number (or first two digits of a 4 digit reference number)identifies the drawing in which the reference number first appears.

Pneumostoma Formation and Anatomy

FIG. 1A shows the chest of a patient indicating alternative locationsfor creating a pneumostoma that may be managed using the system andmethods of the present invention. A first pneumostoma 110 is shown onthe front of the chest 100 over the right lung 101 (shown in dashedlines). The pneumostoma is preferably positioned over the thirdintercostal space on the mid-clavicular line. Thus the pneumostoma 110is located on the front of the chest between the third and fourth ribs.Although the pneumostoma 110 is preferably located between two ribs, inalternative procedures a pneumostoma can also be prepared using aminithoracotomy with a rib resection.

In FIG. 1A, a second pneumostoma 112 is illustrated in a lateralposition entering the left lung 103 (shown in dashed lines). Thepneumostoma 112 is preferably positioned over the fourth or fifthintercostal space under the left arm 104. In general, one pneumostomaper lung is created; however, more or less than one pneumostoma per lungmay be created depending upon the needs of the patient. In most humans,the lobes of the lung are not completely separate and air may passbetween the lobes.

A pneumostoma is surgically created by forming an artificial channelthrough the chest wall and joining that channel with an opening throughthe visceral membrane of the lung into parenchymal tissue of the lung toform an anastomosis. The anastomosis is joined and sealed by sealing thechannel from the pleural cavity using adhesives, mechanical sealingand/or pleurodesis. Methods for forming the channel, opening,anastomosis and pleurodesis are disclosed in applicant's pending andissued patents and applications including U.S. patent application Ser.No. 10/881,408 entitled “Methods and Devices to Accelerate Wound Healingin Thoracic Anastomosis Applications” and U.S. patent application Ser.No. 12/030,006 entitled “Variable Parietal/Visceral Pleural Coupling”which are incorporated herein by reference in their entirety.

FIG. 1B shows a sectional view of chest 100 illustrating the position ofthe pneumostoma 110. The parenchymal tissue 132 of the lung 130 iscomprised principally of alveoli 134. The alveoli 134 are the thinwalled air-filled sacs in which gas exchange takes place. Air flows intothe lungs through the natural airways including the trachea 136, carina137, and bronchi 138. Inside the lungs, the bronchi branch into amultiplicity of smaller vessels referred to as bronchioles (not shown).Typically, there are more than one million bronchioles in each lung.Each bronchiole connects a cluster of alveoli to the natural airways. Asillustrated in FIG. 1B, pneumostoma 110 comprises a channel through thethoracic wall 106 of the chest 100 between two ribs 107. Pneumostoma 110opens at an aperture 126 through the skin 114 of chest 100.

FIG. 1C shows a detailed sectional view of the pneumostoma 110. Asillustrated in FIG. 1C, pneumostoma 110 comprises a channel 120 throughthe thoracic wall 106 of the chest 100 between the ribs 107. The channel120 is joined to cavity 122 in the parenchymal tissue 132 of lung 130.Although shown having a particular shape, the channel 120 and cavity 122will typically conform to the shape of a device inserted into thepneumostoma 110. An adhesion or pleurodesis 124 surrounds the channel120 where it enters the lung 130. The thoracic wall 106 is lined withthe parietal membrane 108. The surface of the lung 130 is covered with acontinuous sac called the visceral membrane 138. The parietal membrane108 and visceral membrane 138 are often referred to collectively as thepleural membranes. Between the parietal membrane 108 and visceralmembrane 138 is the pleural cavity (pleural space) 140. The pleuralcavity usually only contains a thin film of fluid that serves as alubricant between the lungs and the chest wall. In pleurodesis 124 thepleural membranes are fused and/or adhered to one another eliminatingthe space between the pleural membranes in that region.

An important feature of the pneumostoma is the seal or adhesionsurrounding the channel 120 where it enters the lung 130 which maycomprise a pleurodesis 124. A pleurodesis 124 is the fusion or adhesionof the parietal membrane 108 and visceral membrane 138. A pleurodesismay be a complete pleurodesis in which the entire pleural cavity 140 isremoved by fusion of the visceral membrane 138 with the parietalmembrane 108 over the entire surface of the lung 130. However, as shownin FIG. 1C, the pleurodesis is preferably localized to the regionsurrounding the channel 120. The pleurodesis 124 surrounding the channel120 prevents air from entering the pleural cavity 140. If air ispermitted to enter pleural cavity 140, a pneumothorax will result andthe lung may collapse.

Pleurodesis 124 can be created between the visceral pleura of the lungand the inner wall of the thoracic cavity using chemical methodsincluding introducing into the pleural space irritants such asantibiotics (e.g. Doxycycline or Quinacrine), antibiotics (e.g.iodopovidone or silver nitrate), anticancer drugs (e.g. Bleomycin,Mitoxantrone or Cisplatin), cytokines (e.g. interferon alpha-2β andTransforming growth factor-β); pyrogens (e.g. Corynebacterium parvum,Staphylococcus aureus superantigen or OK432); connective tissue proteins(e.g. fibrin or collagen) and minerals (e.g. talc slurry). A pleurodesiscan also be created using surgical methods including pleurectomy. Forexample, the pleural space may be mechanically abraded duringthoracoscopy or thoracotomy. This procedure is called dry abrasionpleurodesis. A pleurodesis may also be created using radiotherapymethods, including radioactive gold or external radiation. These methodscause an inflammatory response and or fibrosis, healing, and fusion ofthe pleural membranes. Alternatively, a seal can be created in an acutemanner between the pleural membranes using biocompatible glues, meshesor mechanical means such as clamps, staples, clips and/or sutures. Theadhesive or mechanical seal may develop into pleurodesis over time. Arange of biocompatible glues are available that may be used on the lung,including light-activatable glues, fibrin glues, cyanoacrylates and twopart polymerizing glues. Applicant's copending U.S. patent applicationSer. No. 12/030,006 entitled “VARIABLE PARIETAL/VISCERAL PLEURALCOUPLING” discloses methods such as pleurodesis for coupling a channelthrough the chest wall to the inner volume of the lung without causing apneumothorax and is incorporated herein by reference for all purposes.

When formed, pneumostoma 110 provides an extra pathway for exhaled airto exit the lung 130 reducing residual volume and intra-thoracicpressure without the air passing through the major natural airways suchas the bronchi 138 and trachea 136. Collateral ventilation isparticularly prevalent in an emphysemous lung because of thedeterioration of lung tissue caused by COPD. Collateral ventilation isthe term given to leakage of air through the connective tissue betweenthe alveoli 134. Collateral ventilation may include leakage of airthrough pathways that include the interalveolar pores of Kohn,bronchiole-alveolar communications of Lambert, and interbronchiolarpathways of Martin. This air typically becomes trapped in the lung andcontributes to hyperinflation. In lungs that have been damaged by COPDand emphysema, the resistance to flow in collateral channels (not shown)of the parenchymal tissue 132 is reduced allowing collateral ventilationto increase. Air from alveoli 134 of parenchymal tissue 132 that passesinto collateral pathways of lung 130 is collected in cavity 122 ofpneumostoma 110. Pneumostoma 110 thus makes use of collateralventilation to collect air in cavity 122 and vent the air outside thebody via channel 120 reducing residual volume and intra-thoracicpressure and bypassing the natural airways which have been impaired byCOPD and emphysema.

By providing this ventilation bypass, the pneumostoma allows stale airtrapped in the parenchymal tissue 132 to escape from the lung 130. Thisreduces the residual volume and intra-thoracic pressure. The lowerintra-thoracic pressure reduces the dynamic collapse of airways duringexhalation. By allowing the airways to remain patent during exhalation,labored breathing (dyspnea) and residual volume (hyperinflation) areboth reduced. Pneumostoma 110 not only provides an extra pathway thatallows air to exit the lung 130 but also allows more fresh air to bedrawn in through the natural airways. This increases the effectivenessof all of the tissues of the lung 130 and improves gas exchange.Increasing the effectiveness of gas exchange allows for increasedabsorption of oxygen into the bloodstream and also increased removal ofcarbon dioxide. Reducing the amount of carbon dioxide retained in thelung reduces hypercapnia which also reduces dyspnea. Pneumostoma 110thus achieves many of the advantages sought by lung volume reductionsurgery without surgically removing a portion of the lung or sealing offa portion of the lung.

Applicants have found that pneumostoma management devices in accordancewith embodiments of the present invention are desirable to maintain thepatency of the pneumostoma and control flow of materials between theexterior of the patient and the parenchymal tissue of the lung via thepneumostoma. The pneumostoma management devices include a pneumostomavent to enter the pneumostoma and allow gases to exit the lung and mayalso include a chest mount, and/or one or more of the tools, packaging,auxiliary device and methods described herein. In general terms apneumostoma management device (“PMD”) or pneumostoma vent comprises atube which is inserted into the pneumostoma and an external componentwhich is secured to the skin of the patient to keep the tube in place.Gasses escape from the lung through the tube and are vented external tothe patient. The pneumostoma management device may, in some, but not allcases, include a filter which only permits gases to enter or exit thetube. The pneumostoma management device may, in some, but not all cases,include a one-way valve which allows gases to exit the lung but notenter the lung through the tube.

Pneumostoma Management Devices

FIGS. 2A and 2B illustrate views of a pneumostoma management device(“PMD”) 200 in accordance with an embodiment of the present invention.PMD 200 is designed so as not to interfere with the range of motion orclothing of the patient. This is of importance for a device such as PMD200 which must be used continuously to be effective. Comfort and ease ofuse are important if patient compliance with treatment protocols is tobe achieved. The low profile of PMD 200 allows it to be inconspicuouslypositioned on the chest 100 of a patient in either the frontal 110 orlateral 112 locations (See FIG. 1A).

PMD 200 includes a pneumostoma vent 204 which is inserted in apneumostoma and secured to the chest of the patient. In someembodiments, the PMD is a single piece device in which a pneumostomavent has a flange which secures the pneumostoma vent directly to theskin of the patient. However, PMD optionally includes a chest mount 202which may be mounted to the skin of the patient and through which thechest vent 204 may be inserted into the pneumostoma. Where an optionalchest mount 202 is utilized, pneumostoma vent 204 is mounted through anaperture 224 in chest mount 202. As will be further described below, theconnection between the chest mount 202 and pneumostoma vent 204 may beengineered so as to ensure that pneumostoma vent 204 cannot beover-inserted into the lung.

A patient will typically wear a PMD at all times and thus the materialsshould meet high standards for biocompatibility. In preferredembodiments, pneumostoma vent 204 is formed frombiocompatible/implantable polymers or biocompatible/implantable metals.In preferred embodiments, chest mount 202 is also formed frombiocompatible polymers or biocompatible metals. Further description ofsuitable materials for manufacturing a PMD are provided in the Materialssection below.

FIGS. 2A and 2B shows a perspective view of a two-component pneumostomamanagement device 200 which includes a pneumostoma vent 204 and anoptional chest mount 202. Chest mount 202 is mounted to the skin of thepatient and pneumostoma vent 204 is fitted to the chest mount 202.Pneumostoma vent 204 is mounted through an aperture 224 in chest mount202. The chest mount is configured so that pneumostoma vent 204 cannotbe over-inserted into the lung and to protect the skin of the chest fromirritation. PMD 200 is preferably disposable. Pneumostoma vent 204 willbe replaced periodically, such as daily, or when necessary. Chest mount202 will also be replaced periodically, such as weekly, or whennecessary. The patient will also be provided with a supply of chestmounts 202 and pneumostoma vents 204 by a medical practitioner or byprescription. A one week supply of pneumostoma vent 204 (such as sevenpneumostoma vents 204) may be conveniently packaged together with onechest mount 202.

Pneumostoma vent 204 includes a tube 240 sized and configured to fitwithin the channel of a pneumostoma and a flange 242. The aperture 224in the chest mount is adapted and configured to receive the tube 240 ofpneumostoma vent 204. A flange 242 is formed in one piece with, orpermanently connected to, the proximal end of tube 240. Flange 242 issufficiently thin and flexible that it can conform to the surface of thechest mount 202. In typical embodiments, flange 242 is less than about 3mm in thickness, and in preferred embodiments, disc 222 is less thanabout 2 mm in thickness. Flange 242 is, however, too large to fitthrough aperture 224, and thus acts as an insertion stop. Flange 242 isshown as a circular disc with a plurality of tabs 244. The distalsurface of flange 242 may be covered in whole or in part with areleasable adhesive 246 adapted to temporarily fix flange 242 to theskin of the patient or to the optional chest mount 202.

Tube 240 is stiff enough that it may be inserted into a pneumostomawithout collapsing. Over time, a pneumostoma may constrict and it is onefunction of PMD 200 to preserve the patency of the channel of thepneumostoma by resisting the natural tendency of the pneumostoma toconstrict. A crush recoverable material may be incorporated into tube240 in order to make it crush recoverable. Tube 240 of pneumostoma vent204 is sufficiently long that it can pass through the thoracic wall andinto the cavity of a pneumostoma inside the lung. The length of tube 240required for a pneumostoma vent 204 varies significantly betweendifferent pneumostomas. Because of the variation in pneumostomas,pneumostoma vents 204 are manufactured having tubes 240 in a range ofsizes and a patient is provided with a pneumostoma vent 204 having atube 240 of appropriate length for the patient's pneumostoma. Thematerial and thickness of tube 240 of pneumostoma vent 204 is preferablyselected such that tube 240 is soft enough that it will deform ratherthan cause injury to the pneumostoma or lung.

Tube 240 of pneumostoma vent 204 preferably comprises an atraumatic tip252 at the distal end as shown in FIGS. 2A and 2B. Tip 252 may berounded, beveled or curved in order to reduce irritation or damage tothe tissues of the pneumostoma or lung during insertion or while inposition. Pneumostoma vent 204 has an opening 254 in tip 252 of tube240. Opening 254 allows the entry of gases from the cavity of thepneumostoma into lumen 258 of tube 240. Tube 240 is optionally providedwith one or more side openings (not shown) positioned near tip 252and/or along the length of tube 240 to facilitate the flow of gas and/ormucous/discharge into lumen 258.

Pneumostoma vent 204 includes a hydrophobic filter 248 over the proximalend of tube 240. Hydrophobic filter 248 is positioned and mounted suchthat material moving between lumen 258 and the exterior of pneumostomavent 204 passes through hydrophobic filter 248. Hydrophobic filter 248may also be selected to prevent the entry of microbes, pollen and otherallergens and pathogens into the lumen 258. Hydrophobic filter 248 alsoprevents the exit of liquid and particulate discharge from lumen 258 tothe exterior of pneumostoma vent 204. Hydrophobic filter 248 ispreferably designed such that it fits into a recess in flange 242.However, hydrophobic filter 248 is thin and flexible and thus will notprotrude far if affixed to the surface of flange 242. Hydrophobic filter248 may be permanently attached to flange 242, as shown in FIG. 2B.Hydrophobic filter 248 may be permanently attached to flange 242 using apress fitting, permanent adhesive, welding or other bonding technology.Flange 242 of pneumostoma vent 204 is releasably connected to chestmount 202 during use. Hydrophobic filter 248 may be made from a materialsuch as medical grade GOR-TEXJ (W. L. Gore & Associates, Inc.,Flagstaff, Ariz.) or a reticulated polyurethane-based open cell foam.

Hydrophobic filter 248 serves several purposes. In general, hydrophobicfilter 248 controls the passage of solid or liquid material between thelumen 258 and the exterior of cap 242. For example, hydrophobic filter248 prevents the flow of water into the lumen 258 through proximalopening 255. Thus, a patient using PMD 200 may shower without waterentering the lung through the pneumostoma. Hydrophobic filter 248 mayalso be selected so as to prevent the entry of microbes, pollen andother allergens and pathogens into the lumen 258. Hydrophobic filter 248also prevents the exit of liquid and particulate discharge from lumen258 to the exterior of pneumostoma vent 204. This is desirable toprevent contact between liquid and particulate discharge and clothingfor example.

Pneumostoma vent 204 may mount directly to the skin of the chest or toan optional chest mount 202 which is secured to the chest of thepatient. In one embodiment, illustrated in FIGS. 2A and 2B, chest mount202 comprises a flange 222 and an aperture 224. Chest mount 202 includesa thin and flexible disc 222 designed to conform to the chest of thesubject. Disc 222 is generally circular but is provided with one or moretabs 236 to facilitate application and removal of disc 222 from the skinof the patient. In typical embodiments, disc 222 is less than about 3 mmin thickness, and in preferred embodiments, disc 222 is less than about2 mm in thickness. However, the disc may be thicker if absorbingrequirements of the discharge around the tube is high. Additionally athicker disk may provide a forgiving surface to apply the flange to arough or highly contoured skin surface. Disc 222 is thus sufficientlyflexible that it can conform to the surface of the chest but isrelatively inelastic so that the size and shape of aperture 224 isrelatively stable. Disc 222 has a contact surface 232 which contacts theskin of the patient surrounding the pneumostoma and positions theaperture 224 over the opening of the pneumostoma. Contact surface 232 ofdisc 222 is provided with a biocompatible adhesive 234, such as ahydrocolloid adhesive, for securing disc 222 to the skin of the patient.The adhesive 234 may be protected by a protector sheet that is removedprior to use of disc 222. Adhesive 234 should be selected so as tosecure disc 222 to the chest of the patient in the correct positionrelative to the pneumostoma without causing undue irritation to the skinof the patient. The adhesive need not create an air tight seal betweendisc 222 and the skin of the patient indeed, as described above, it maybe desirable to allow air to circulate behind disc 222 so that moisturedoes not accumulate. Moisture may also be allowed to escape by makingdisc 222 from a porous material or creating pores in the material ofdisc 222.

The aperture 224 is adapted and configured to receive the pneumostomavent 204. In a preferred embodiment, the dimensions of aperture 224 aretightly controlled and the size and shape of aperture 224 remains stableeven under any reasonably possible application of force to chest mount202. The size of the aperture limits what components of the system mayenter the pneumostoma and prevents components from passing completelyinto the pneumostoma. All the components of the pneumostoma vent 204(other than the distal end of tube 240) and chest mount 202 or othertools designed for use by the patient are preferably larger than theaperture 224 thus precluding passage of any component from passingcompletely through the aperture even in the unlikely event of devicefailure. These safety features prevent unsafe entry of any of thecomponents of pneumostoma vent 204 into pneumostoma even in the unlikelyevent of device failure.

In an alternative embodiment shown in FIG. 2C, hydrophobic filter 248 isreleasably attached to flange 242 of a pneumostoma vent 260. Hydrophobicfilter 248 may, for example, be releasably attached to flange 242 usinga joint such as a threaded coupling or snap fitting. As shown in FIG.2C, a ring 263 surrounding hydrophobic filter 248 snaps into place in areceiver 268 in flange 242. Hydrophobic filter 248 may be removed bypulling on tab 264. Removal of hydrophobic filter 248 allows access tolumen 258 while pneumostoma vent 260 is still positioned in thepneumostoma. This also allows access to the pneumostoma via the tube 240of pneumostoma vent 260. Access to the pneumostoma may be useful, forexample, for suction, irrigation and/or drug delivery. The pneumostomavent 260 of FIG. 2C may be used with or without the chest mount 202 ofFIGS. 2A and 2B.

It is not necessary that a flow-control device be used in a pneumostomavent to form an airtight seal against the entry of air into the lungthrough the pneumostoma. Indeed, air may enter the lung through thepneumostoma between removal and reinsertion of the pneumostoma vent 204.The pleurodesis of the pneumostoma prevents the entry of air into thepleural cavity which would otherwise cause pneumothorax. However, it issometimes desirable to restrict flow of air in through the pneumostomaso as to encourage a reduction in hyperinflation and to preclude theaspiration of solid, liquid or gas into the lung through thepneumostoma. Thus, in alternative embodiments a pneumostoma vent may beprovided with a flow control device instead of, or in addition to, thehydrophobic filter 248. The flow-control device may comprise a one-wayvalve assembly such as a flapper valve, Heimlich valve, reed valve orthe like for allowing air to be exhaled with very low resistance throughthe pneumostoma while restricting the flow of air or other matter intothe pneumostoma from outside the body. A suitable flow-control devicepreferably includes only a small number of components for ease ofmanufacturing and reliability and should be designed such that it has nosmall parts which might be aspirated through the pneumostoma.

FIGS. 3A-C illustrate an alternative pneumostoma management device 300having a combination hydrophobic filter and one-way valve. PMD 300includes a pneumostoma vent 304. Pneumostoma vent 304 includes a tube340 formed in one piece with a flange 342. Flange 342 is also thin andflexible so that it may conform to the chest of the patient. In typicalembodiments, flange 342 is less than about 3 mm in thickness, and inpreferred embodiments, flange 342 is less than about 2 mm in thickness.Flange 342 has one or more tabs 344 to facilitate insertion and removal.The distal surface of flange 342 may be covered in whole or in part witha releasable adhesive 346 adapted to temporarily fix flange 342 to thechest of the patient. PMD 300 may optionally include a chest mount suchas chest mount 202 of FIG. 2A (not shown in FIG. 3A).

A combination hydrophobic filter and one-way valve 347 is attached toflange 342 over the proximal end of tube 340. Valve 347 includes anannular region 348 of porous hydrophobic material and a centralnon-porous region 349. Valve 347 is attached to the flange at thecircumference. As shown in FIG. 3B, when the pressure outside thepneumostoma is larger than the pressure inside the pneumostoma, valve347 is pushed against flange 342 and non-porous region 349 blocks theproximal end of tube 340. This prevents entry of gases through thepneumostoma during inhalation or in the event of sudden pressureincreases in the environment. As shown in FIG. 3C, when the patientexhales, the increased pressure inside tube 340 pushes valve 347 awayfrom the proximal end 352 of tube 340. Gases can then pass radially outof tube 340 and escape through the porous annular region 348 as shown byarrows 350. Thus valve 347 provides a simple way to provide one-wayvalve and filter functionality to pneumostoma vent 304. Otherarrangements of valves and/or filters may be used in alternativeembodiments.

The pneumostoma vents of FIGS. 2A-2C and 3A-3C are designed to beinserted into a pneumostoma and removed from a pneumostoma without theneed for special tools. A releasable adhesive or releasable couplingtemporarily secures the pneumostoma vent to the chest of the patient (oroptional chest mount). One or more tabs allow the pneumostoma vent to bepeeled away from the chest of the patient (or optional chest mount) andremoved. The tabs should be made sufficiently large that they can beused by the patients. It may additionally be useful to provide analignment tool for aligning the aperture of the chest mount with thepneumostoma during application of the chest mount to the skin of thechest. It may also be useful to provide a plug which may be used toprotect the pneumostoma from the entry of foreign material during timesof activities when a pneumostoma vent is not present in chest mount. Thealignment tool and/or pneumostoma plug are designed to engage the chestmount in the same way as the pneumostoma vent, for example, by using areleasable adhesive or other releasable coupling.

FIGS. 4A-4F show views of alternative designs of pneumostoma vent. Asshown in FIG. 4A, pneumostoma vent 400 includes a tube 404 and a flange402. Flange 402 is thin and flexible so that it may conform to the chestof the patient or an optional chest mount (such as chest mount 202 ofFIG. 2A). In typical embodiments, flange 402 is less than about 3 mm inthickness, and in preferred embodiments, flange 402 is less than about 2mm in thickness. Flange 402 may be provided with one or more tabs (notshown) to facilitate insertion and removal. The distal surface of flange402 is covered in whole or in part with a releasable adhesive (see FIG.4C). The adhesive is adapted to temporarily secure flange 402 to thechest of the patient (or chest mount if used). The size, shape andthickness of the flange 402 are selected to facilitate installation andenhance the comfort of the patient during use while maintaining thecorrect placement of tube 404 in the pneumostoma. Tube 404 has anatraumatic tip 405 and an aperture 407 at the distal end. Flange 402 maybe generally circular as shown in FIG. 4A. In the alternative embodimentof FIG. 4B flange 412 of pneumostoma vent 410 is generally strip-shapedor rectangular. A hydrophobic filter 408 is mounted to the flange 402 or412 over the proximal opening of tube 404. In the embodiments of FIGS.4A-4C, hydrophobic filter 408 is a thin disc of hydrophobic materialwhich is press fit into a raised region 406 of the flange 402 or 412.The sectional view of the pneumostoma vent 400 of FIG. 4A shown in FIG.4C illustrates one way in which interference between hydrophobic filter408 and raised region 406 can secure hydrophobic filter 408. Inalternative embodiments, a hydrophobic filter may be secured to theflange using adhesive or other bonding methods. Other arrangements ofvalves and/or filters may be used instead of or in addition to thehydrophobic filter shown.

As previously discussed, the length of tube 440 required for apneumostoma vent 404 varies significantly between differentpneumostomas. Because of the variation in pneumostomas, pneumostomavents 404 should be manufactured having tubes 440 in a range of sizesand a patient should be provided with a pneumostoma vent 404 having atube 440 of appropriate length for the patient's pneumostoma.Pneumostoma vents 404 having different lengths of tube 440 may bemanufactured in a number of different ways. FIGS. 4C-4F and 5A-5Cillustrate designs which facilitate the manufacture of pneumostoma ventshaving a range of different lengths.

FIG. 4C is a sectional view of pneumostoma vent 400 of FIG. 4A madeaccording to one alternative embodiment. As shown in FIG. 4C, tube 404is formed as a separate piece from flange 402. Tube 404 is connected ata butt joint 420 to a tubular extension 422 of flange 402. Butt joint420 may be adhesively bonded, welded or otherwise secured. A singleshape of mold/tooling can be used to make all of the flanges 402 for alllengths of pneumostoma vent 400. Tube 404 can be advantageously formedusing an extrusion process. The extruded tube can be cut to any desiredlength and then tipped to create atraumatic tip 405 around distalaperture 407. Different lengths of tube 404 can be bonded to flange 402to create a range of different lengths of pneumostoma vent 400 withoutrequiring different tooling for each size of pneumostoma vent.Additionally, a different material may be used to make flange 402 thantube 404. For example, a softer more conformable material may be usedfor flange 402 to allow it to conform to the chest of the patient. Aharder material may be used for tube 404 to allow it to resist crushingwhile having a thin wall thickness and consequently a large innerdiameter for the passage of air. An adhesive 403 is placed on the distalsurface of flange 402 to releasably secure the flange to the chest ofthe patient (or a chest mount if present).

FIG. 4D is a sectional view of pneumostoma vent 440 made according toanother alternative embodiment. As shown in FIG. 4D, tube 444 is againformed as a separate piece from flange 442. A single shape ofmold/tooling can again be used to make all of the flanges 442 for alllengths of pneumostoma vent 440. Also tube 444 can be advantageouslyformed using an extrusion process. As before, the extruded tube can becut to any desired length and then tipped to create atraumatic tip 405around distal aperture 407. Different lengths of tube 444 can be bondedto flange 442 to create a range of different lengths of pneumostoma vent440 without requiring different tooling for each size of pneumostomavent 440. Additionally, a different material may be used to make flange442 than tube 444. For example a softer more conformable material may beused for flange 442 to allow it to conform to the chest of the patient.A harder material may be used for tube 444 to allow it to resistcrushing while having a thin wall thickness and consequently a largeinner diameter for the passage of air. In the embodiment of FIG. 4D, aflare 449 is formed at the proximal end of tube 444. Tube 444 isreceived through aperture 447 in flange 442. However flare 449 is toolarge to pass through aperture 447 and therefore engages the rim 441around aperture 447. Flare 449 is securely connected to rim 441 offlange 442. Flare 449 may be adhesively bonded, sealed, welded orotherwise secured to rim 441. This design is advantageous in that flare449 is too large to fit through aperture 447 even if the joint failsbetween the flare 449 and rim 441. As before, the extruded tube 444 canbe cut to any desired length and then tipped to create atraumatic tip405 around distal aperture 407. Different lengths of tube 444 can bebonded to flange 442 to create a range of different lengths ofpneumostoma vent 404 without requiring different tooling for each sizeof pneumostoma vent. A hydrophobic filter 448 is secured within raisedregion 446 of flange 442 and an adhesive 443 is applied to the distalsurface of flange 442 as in previous embodiments.

FIG. 4E is a sectional view of pneumostoma vent 450 made according toanother alternative embodiment. As shown in FIG. 4E, tube 454 is againformed as a separate piece from flange 452 for the same advantagespreviously discussed with respect to FIGS. 4C and 4D. In the embodimentof FIG. 4E, flange 452 is formed with tubular extension 451 having aplurality of ridges 457. Tubular extension 451 functions like a hosebarb. The proximal end 459 of tube 454 is pushed over tubular extension451 and is deformed by ridges 457. The ridges 457 are designed to securetube 454 to flange 452 without adhesive. However an adhesive or otherbonding technology may be used in addition to the mechanical connectionafforded by tubular extension 451. As before, the extruded tube 454 canbe cut to any desired length and then tipped to create atraumatic tip405 around distal aperture 407. Different lengths of tube 454 can bebonded to flange 452 to create a range of different lengths ofpneumostoma vent 450 without requiring different tooling for each sizeof pneumostoma vent 450. A hydrophobic filter 458 is secured withinraised region 456 of flange 452 and an adhesive 453 is applied to thedistal surface of flange 452 as in previous embodiments.

FIG. 4F is a sectional view of a pneumostoma vent 460 made according toanother alternative embodiment. As shown in FIG. 4F, tube 464 is againformed as a separate piece from a flange 462 for the same advantagespreviously discussed with respect to FIGS. 4C and 4D. In the embodimentof FIG. 4D, flange 462 is a small disc with a raised region 466 forreceiving hydrophobic filter disc 468. Flange 462 has a small extension461 which extends into tube 464. Tube 464 is formed integral with twoarms 467, 469 which extend perpendicular to tube 464. The arms 467, 469are formed by splitting tube 464 in half along a length equal to thelength of arms 467, 469. The two parts of tube 464 are then bentperpendicular to tube 464, hot pressed and trimmed to make arms 467,469. Flange 462 is then bonded to the proximal opening of tube 464 andto arms 467, 469 and serves to hold filter 468 and also to keep arms467, 469 perpendicular to tube 464. An adhesive or other bondingtechnology may be used in addition to the mechanical connection affordedby the extension. As before, the extruded tube 464 can be cut to anydesired length and then tipped to create atraumatic tip 405 arounddistal aperture 407. Different lengths of tube 464 can be bonded toflange 462 to create a range of different lengths of pneumostoma vent460 without requiring different tooling for each size of pneumostomavent. A hydrophobic filter 468 is secured within raised region 466 offlange 462 and an adhesive 463 is applied to the distal surface offlange 462 as in previous embodiments. Although two arms 467, 469 areshown in FIG. 4F, in alternative embodiments, tube 464 can be split intothree, four or more sections to make three, four or more arms. See FIG.6E for an example with ten arms.

In alternative embodiments, as illustrated in FIGS. 5A-5C, the flangeand tube can be formed in one piece. However, it is still advantageousto use a minimum of tooling to make the pneumostoma vent of varioussizes. One way to avoid having different molds/tooling for each size ofpneumostoma vent is to make all of the pneumostoma vents with the samelength of tube. If the tube length is selected to be longer than thelongest tube needed for a pneumostoma, then the tube can be trimmed tothe desired size and tipped to form the atraumatic tip 405 at the distalend.

FIG. 5A shows one design with an integrated flange 502 and tube 504.Note that the inside diameter 570 of tube 504 reduces in size towardsthe open distal tip 571. It is desirable to have this draft in theinside diameter 570 of tube 504 to enable the tube 504 to be removedfrom the pin of the tooling/mold. Thus tube 504 can be reduced inexterior diameter along its length, or the exterior diameter can bepreserved the same and the inner diameter 570 can be reduced as shown.One disadvantage of this design is that the inner diameter 570 may besignificantly reduced for long lengths of tube 504. It is preferred,where possible, that the inner diameter 570 be as large as possible,especially for longer tubes 504 so that air and discharge may moreeasily pass along the tube 504.

After the integrated flange 502 and tube 504 has been removed from thetooling/mold, the tube 504 can be trimmed to the desired length. The cutend of tube 504 can then be tipped to form the atraumatic tip 505 aroundthe aperture 507 at the distal end of the finished tube 504. Thepneumostoma vent 500 may be completed by adding the other components,for example a hydrocolloid adhesive and hydrophobic filter.

FIGS. 5B and 5C show an alternative design of pneumostoma vent featuringan integrated flange 512 and tube 514. Note that in this design, tube514 is initially closed at the distal end 572. Because tube 514 isclosed when molded it may be blown off the pin of the mold/toolingoccupying the interior of tube 514 using compressed air. This designallows tube 513 to be removed from the tooling/mold without any draft(reduction in inner diameter 580). This design is advantageous as itallows the inner diameter 580 of tube 514 to be kept constant along thelength of tube 514. After the integrated flange 512 and tube 514 havebeen removed from the tooling/mold, the tube 514 can be trimmed to thedesired length for example along line C-C. The cut end of tube 514 canthen be tipped to form the atraumatic tip 505 around the aperture 507 atthe distal end of the finished tube 514 as shown in FIG. 5C. FIG. 5Cshows tube 514 cut to length and tipped. The closed portion 586 of tube514 has been cut off and may now be recycled or discarded. Thepneumostoma vent 510 may be completed by adding the other components,for example, a hydrocolloid adhesive and hydrophobic filter.

FIGS. 6A-6C shows different views of a pneumostoma vent system 600.Pneumostoma vent system 600 is designed for use without a chest mountalthough it could be adapted for use with a chest mount. FIG. 6A showsan exploded view of the four main components of pneumostoma vent system.From right to left these components are annular adhesive cover 602,filter 604, pneumostoma vent 606 and hydrocolloid ring 608.

Annular adhesive cover 602 is a thin porous biocompatible membrane whichis adhesive on the surface facing the pneumostoma (the inner surface see622 in FIG. 6C) and non-adhesive on the outer surface 620. A suitablematerial for annular adhesive cover 602 is a CHG Chlorhexidine GluconateIV Securement Dressing available under the Tradename TEGADERM™ from 3Mof St. Paul, Minn. TEGADERM™ is thin layer of polyurethane bonded to athin hydrocolloid adhesive layer. The film is biocompatible as well asthin, strong, and breathable. Other thin biocompatible dressings andadhesive films may be used as an alternative to TEGADERM™ Annular cover602 has an aperture 624 large enough to allow air to exit through filter604. Aperture 624 may however be slightly smaller than filter 604 sothat annular cover can be used to secure filter 604 to pneumostoma vent606. Exposed portions of annular adhesive cover 602 are provided with apaper cover to protect the adhesive ring prior to use.

Filter 604 is a circular disc of filter material. Filter 604 ispreferably a hydrophobic filter material, for example GORETEX. Filter604 is larger than the proximal aperture in pneumostoma vent 606 and ispositioned over the proximal aperture to filter material moving in andout of the pneumostoma vent 606. Filter 604 may be secured topneumostoma vent 606 by and adhesive, welding, or other bondingtechnology. Filter 604 may also be secured to pneumostoma vent 606 byannular adhesive cover 602 instead of or in addition to other bondingtechniques.

Pneumostoma vent 606 comprises a tube 660 for entering the pneumostoma.As previously discussed, tube 660 has an atraumatic tip 665 and one ormore apertures 667 in the distal end to allows gases and discharge toenter tube 660 from the pneumostoma. Tube 660 is connected to a flange662 at the proximal end. Flange 662 may be formed in one piece with tube660 or formed separately and joined to tube 662 as previously describedwith respect to other embodiments. Filter 604 is secured over proximalopening 663 as described in the previous paragraph. The proximal opening663 of pneumostoma vent is sized so that filter 604 covers proximalopening 663.

Hydrocolloid ring 608 is a biocompatible hydrocolloid material which isnaturally sticky like an adhesive on both sides. Hydrocolloid ring maybe provided with a film coating and a transitional adhesive on the sidefacing flange 662 and annular cover 602 in order to better securehydrocolloid ring 608 to the flange and annular cover. Hydrocolloid ring608 is preferably less than 3 mm thick and is more preferably,approximately 1 mm in thickness. However, the hydrocolloid ring may bethicker if absorbing requirements of the discharge around the tube ishigh. Additionally a thicker ring of hydrocolloid may provide aforgiving surface to secure pneumostoma vent system 600 to a rough orhighly contoured skin surface. Exposed portions of hydrocolloid ring 608are provided with a paper cover to protect the adhesive ring prior touse.

Pneumostoma vent system 600 may be provided as a kit of separatecomponents or one or more of the components may be preassembled whenprovided to the patient. FIG. 6B shows an assembly of all four maincomponents including annular adhesive cover 602, filter 604, pneumostomavent 606 and hydrocolloid ring 608. Note that tube 660 fits through themiddle of hydrocolloid ring 608. Note also that flange 662 is trappedbetween annular adhesive cover 602 and hydrocolloid ring 608. In thisembodiment, filter 604 is also secured to pneumostoma vent 606 byannular adhesive cover 602. Exposed adhesive regions of annular adhesivering 602 and hydrocolloid ring 608 on the patient side of thepneumostoma vent system assembly are provided with protective covers(for example paper covers) to protect the adhesive during shipping andprior to use. The completed or partially completed assembly is providedas a sterile product to the patient or caregiver who inserts thepneumostoma vent into a pneumostoma as part of a pneumostoma careprogram.

FIG. 6C shows the pneumostoma vent system 600 in position within apneumostoma 110. As shown in FIG. 6C, tube 660 is inserted into thepneumostoma and passes through the chest wall into the lung. Aperture667 in the distal end of tube 660 is positioned inside the lung so thatgases and discharge may enter the tube 660 of the pneumostoma ventsystem. Flange 662 of pneumostoma vent 606 is secured to the skin of thepatient by hydrocolloid ring 608 and annular adhesive cover 602. Flange662 secures the position of tube 660 within pneumostoma 110. Flange 662secures the position of aperture 663 on the chest of the patient suchthat gases from the lung may vent through tube 660 and filter 604. Bothhydrocolloid ring 608 and annular adhesive cover 602 contact the skin114 of the patient to secure the pneumostoma vent system. In some casesa barrier film may be applied by the patient prior to securing thepneumostoma vent system to reduce skin irritation caused by applicationand removal of the system. An additional ring of absorbent material (notshown), for example, gauze or another absorbent fabric may be positionedaround tube 660 between hydrocolloid ring 608 and the skin 114 of thepatient for absorbing any discharge from pneumostoma 110 which escapesaround tube 660.

As shown in FIG. 6D a pneumostoma vent system 620 may be provided in anumber of shapes and sizes to suit the needs and anatomy or differentpatients. In pneumostoma vent system 620, adhesive cover 622 isgenerally rectangular or strip-like in shape with an aperture 623through which filter 624 is exposed. Hydrocolloid ring 628 is oval inshape so that it fits within the coverage of adhesive cover 622.Assembly of pneumostoma vent system is essentially as described withrespect to pneumostoma vent system 600. Filter 624 is sandwiched betweenpneumostoma vent 626 and adhesive cover 622. Tube 625 of pneumostomavent 626 passes through the middle of hydrocolloid ring 628. Flange 627of pneumostoma vent 626 is sandwiched between hydrocolloid ring 628 andadhesive cover 622. A protective backing is added to protect the exposedadhesive surfaces prior to application to the patient.

In the alternative embodiment of FIG. 6E, pneumostoma vent 636 has aflange which comprises ten arms 637. The arms 637 may be made, forexample by splitting the proximal end of tube 635 into slices which arethen bent perpendicular to tube 635. The arms 637 may be sandwichedbetween hydrocolloid ring 638 and adhesive cover 632 as before.Alternatively, the arms 637 may be distributed and embedded within ahydrocolloid layer. As before, adhesive cover 632 secures filter 634over the proximal opening in tube 635.

FIG. 6F shows an alternative kit 680 in which a smaller cover 682,filter 604, pneumostoma vent 606 and hydrocolloid ring 608 arepreassembled and provided together with a secondary cover 690. In thisembodiment, cover 682 is approximately the same size as hydrocolloidring 608 and thus does not contact the skin of the patient but servesonly to secure filter 604 and flange 662. Note that tube 660 extendsthrough hydrocolloid ring 608. Flange 662 and filter 604 are trapped andsecured between smaller cover 682 and hydrocolloid ring 608. Exposedadhesive regions of hydrocolloid ring 608 on the patient side of thepneumostoma vent system 600 are provided with protective covers (forexample paper covers) to protect the adhesive during shipping and priorto use. The two components are provided as a sterile kit to the patientor caregiver. The pneumostoma vent is first secured in the pneumostoma.The secondary cover is applied over the top of the pneumostoma vent. Thesecondary cover 690 is designed not to block the flow of air throughfilter 604. Secondary cover 690 is either sufficiently porous to allowair to pass or is provided with one or more openings to allow air topass.

In order to increase air flow through the filter a filter material withlow to extremely low resistance to air flow is preferred. The resistanceof the filter to air flow may be reduced by increasing the area of theair filter through which air may pass. The surface area of the filtermay be increased in several ways. First the filter area may be increasedby flaring out the proximal aperture in the pneumostoma vent andconsequently a larger filter 604. Second the filter can be folded,shaped or pleated to increasing the area of filter material for a givenaperture. Third, as shown in FIG. 3C, the filter can be arranged suchthat a filter larger than the aperture may be utilized. FIG. 6G shows analternate pneumostoma vent system 600 g having a flare 640 in theproximal end of pneumostoma vent 606 g. As shown in FIG. 6G, the flare640 increases the diameter of the proximal opening 663 of pneumostomavent 606 g by approximately 50%. As a consequence, the area of proximalopening 663 and filter 604 g through which gases may escape isapproximately doubled compared to the pneumostoma vent system 600 with anon-flared pneumostoma vent 606 (see FIG. 6C).

FIG. 6H shows an alternate pneumostoma vent system 600 h having aconical filter 604 h received within pneumostoma vent 606. Conicalfilter 604 h presents approximately four times the surface area for airflow as compared to the flat circular filter 604 of pneumostoma ventsystem 600 with the same diameter of proximal opening 663 (see FIG. 6C).FIG. 6I shows a perspective view of conical filter 604 h. As shown inFIG. 6J, the surface area of filter 604 j is increased even further byinclusion of numerous folds/pleats 650 in the material of filter 604 j.These techniques for increasing the area of the filter may be used aloneor in combination in any of the pneumostoma management devices disclosedherein.

The components of the pneumostoma management system are preferablysupplied to the patient in sterile packaging. In preferred embodiments,the components are supplied in packaging that assists the patient inutilizing the components of the system in the correct sequence. Thepackaging should include instructions for use. The packaging may also beprinted with material that assists the patient in the appropriatesequence of the steps for using the enclosed components. The package mayalso be designed to provide the components to the patient in the orderrequired for use and maintain sterility during use. For example, thepackage may be designed so that, upon opening the package, thecomponents are physically arranged in a tray in the order in which theyare to be used by the patient. Alternatively, the components may beprovided as individual components separately packaged. For example,cleaning and moisturizing swabs and barrier spray/cream mayalternatively or additionally be packaged separately and provided topatient. The insertion tool, removal tool and pneumostoma vent may alsobe separately packaged.

Use Of Pneumostoma Management Devices

The pneumostoma management system is designed such that the system maybe used by a patient in a sterile manner. After creating and healing ofthe pneumostoma the patient will be responsible for applying andremoving the PMD and components thereof such as the pneumostoma vent 204and chest mount 202 (if used). The patient will typically exchange onepneumostoma vent 204 for another and dispose of the used pneumostomavent 204. Pneumostoma vent 204 will be replaced periodically, such asdaily, or when necessary. The patient will be provided with a supply ofpneumostoma vents 204 by a medical practitioner or by prescription. Toavoid irritation to the chest, it is preferable that the chest mount, ifprovided, be changed less frequently than the pneumostoma vent. In apreferred embodiment, the chest mount remains attached for up to a weekthereby avoiding irritation of the skin caused by daily attachment andremoval of a mount. Chest mount 202 will be replaced periodically, suchas weekly, or when necessary. The patient will also be provided with asupply of chest mount 202 by a medical practitioner or by prescription.A one week supply of pneumostoma vent 204 (such as seven pneumostomavents 204) may be conveniently packaged together with one chest mount202. Where a chest mount is not used, a barrier cream or spray may beused to protect the skin of the chest from irritation.

To use PMD 200, chest mount 202 is first positioned over a pneumostomaand secured with adhesive to the skin of the patient. Chest mount may bepositioned by the patient by manual alignment of the aperture 224 ofchest mount 202 with the aperture of the pneumostoma. In one embodiment,the chest mount 202 may be aligned with the pneumostoma 110 using apneumostoma vent 204 assembled with the chest mount 202. The chest mount202 may be provided to the patient with the pneumostoma vent 204 as oneassembly. Alternatively, the patient may insert the pneumostoma vent 204into the chest mount 202 prior to applying chest mount 202 to the chest.The patient then manipulates the chest mount by the tabs 236. Thepatient places the tip 252 of pneumostoma vent 204 into the aperture 126of the pneumostoma 110 and pushes the pneumostoma vent 204 gently andslowly into the pneumostoma 110. During insertion the patient lets thepneumostoma vent 204 align itself with the channel 120 of thepneumostoma 110 such that when the chest mount 202 contacts and adheresto the skin 114 of the chest 100, the aperture 224 of the chest mount202 is perfectly aligned with the aperture 126 of the pneumostoma 110. Apneumostoma vent 204 may be inserted in the same way without a chestmount 202 if the particular PMD used does not come with a chest mount202.

FIG. 7A provides a set of instructions for use (IFU) 720 for replacementof a chest mount according to an embodiment of the invention. At step722, the patient obtains the replacement chest mount and verifies thatit is the correct size for his/her pneumostoma. At step 724, the patientremoves the prior chest mount and disposes of it as appropriate. At step726, the patient removes a sterile cleaning swab from the chest mountpackage. At step 728, the patient cleans the area of the skin around thepneumostoma. The patient cleans in a direction radially out from thepneumostoma. At step 730, the patient inspects the tissue around thepneumostoma and the pneumostoma for inflammation or injury. If injury orinflammation is observed the patient should seek medical advice.

At step 732, the patient removes a new disposable (or sterilizedreusable) chest mount from its packaging. At step 734, the patientremoves the backing from the adhesive pad of the chest mount. Care istaken during steps 732 and 734 to handle the chest mount only by thetabs and not to touch the surface which will be in contact with thepneumostoma. At step 736, the patient applies the chest mount to thepneumostoma aligning the aperture of the chest mount with the apertureof the pneumostoma. Chest mount may be packaged with an alignment toolor assembled with a pneumostoma vent to assist in positioning chestmount correctly. If pain or injury is perceived during application thepatient should seek medical advice. The steps of IFU 720 may also beperformed by a caregiver or medical practitioner.

FIG. 7B provides a set of instructions for use (IFU) 740 for replacementof a pneumostoma vent according to an embodiment of the invention. Atstep 742, the patient obtains the replacement pneumostoma vent andverifies that it is the correct size for his/her pneumostoma. Thepackaging of the pneumostoma vent is clearly marked with the length ofthe pneumostoma vent. In addition, the pneumostoma vent can be colorcoded either on the cap or tube such that a particular color indicates aparticular length of pneumostoma vent. At step 744, the patient removesthe used pneumostoma vent by pulling on the flange or tabs. The patientcleans or disposes of the used pneumostoma vent as appropriate. At step746, the patient removes a sterile cleaning swab from the chest mountpackage and cleans the chest mount or the area of the skin around thepneumostoma if no chest mount is used. The patient cleans in a directionradially out from the pneumostoma. At step 748 the patient inspects thetissue around the pneumostoma and the pneumostoma for inflammation orinjury. If injury or inflammation is observed the patient should seekmedical advice.

At step 750, the patient removes a new pneumostoma vent from thepackaging. The patient does not directly touch the tube of thepneumostoma vent. Patient grips the flange or tabs of the newpneumostoma vent. At step 752, the patient removes the protectivecovering on the back of the pneumostoma vent exposing the adhesive. Atstep 754, the patient aligns the tip of the tube of the new pneumostomavent with the pneumostoma and inserts the tube until the flange is incontact with the chest of the patient or the chest mount. Care is takenduring steps 750, 752 and 754 to handle the pneumostoma vent only by thetabs and/or flange and not to touch the sterile tube of the pneumostomavent. If pain or injury is perceived during insertion of pneumostomavent the patient should seek medical advice. The steps of IFU 740 mayalso be performed by a caregiver or medical practitioner.

Accessories For Pneumostoma Management Devices

FIGS. 8A and 8B shows views of a pneumostoma plug 840 which may be usedto protect the pneumostoma from the entry of foreign material duringtimes or activities when a pneumostoma vent is not present in thepneumostoma or when it is necessary or desirable to close thepneumostoma for activities such as, for example, spirometry testing oflung function or swimming. As shown in FIG. 8A, pneumostoma plug 840includes a cover 842 for covering the external aperture in the chest orchest mount 202. The cover 242 preferably conforms to the outsidesurface 235 of chest mount 202 or chest to form a functional seal of theaperture. If the exterior surface of cover 842 is subjected to increasedpressure such as by water pressure when swimming, cover 842 is pushedinto better contact with surface 235 making a better seal and precludingthe entry of water. Pneumostoma plug 840 has a recessed handle 846 orsimilar gripping mechanism to allow plug 240 to be grasped by thepatient and removed when necessary. One or more tabs 848 may be providedon the periphery of cover 842 to allow the cover to be grasped by thepatient to remove pneumostoma plug 840. Tabs 848 may be provided insteadof or addition to handle 846. Plug 840 is however preferably low profileso as to avoid being caught and removed accidentally during an activity.Cover 842 is coated on one side with a releasable adhesive 850 (shown inFIG. 8B) to secure the cover to the chest mount or chest of the patient.Adhesive 850 ensures that pneumostoma plug 840 stays in place andremains there until removed by the patient. Note that cover 842 andchest mount engagement section 850 are large enough to precludepneumostoma plug 840 from passing through the pneumostoma.

Referring again to FIGS. 8A and 8B, pneumostoma plug 840 includes astopple 852 sized and configured to pass into the pneumostoma (and passthrough the aperture of the chest mount if present) into the pneumostomaand to fill the pneumostoma tightly so as to prevent the entry or exitof material through the pneumostoma. Stopple 852 preferably has anatraumatic tip 854 which is soft, and or curved to facilitate insertionof stopple 852 and reduce irritation to the pneumostoma. Note thatstopple 852 may be relatively short compared to a pneumostoma vent suchthat stopple 852 preferably does not penetrate beyond the end of thechannel of pneumostoma. Stopple 852 may, alternatively, be as long asthe pneumostoma vent the patient typically uses. Stopple 852 ispreferably designed so as to preclude contact of stopple 852 with lungparenchymal tissue during vigorous activity. The surface of stopple 852may also be provided with surface features such as ridges (not shown) tomake a better seal of the pneumostoma. Pneumostoma plug 840 may bedesigned for use with or without a chest mount 202.

FIGS. 8C and 8D illustrate an alternative pneumostoma plug 860 designedto operate in conjunction with a pneumostoma vent 204. Pneumostoma plug860 comprises a cover 862 designed to engage the flange 242 ofpneumostoma vent 203 (it may also engage chest mount 202 if present).Note that pneumostoma plug 860 is designed such that it will not fitthrough the aperture of chest mount 202, if present, and will not fitentirely into the pneumostoma. Pneumostoma plug 860 is provided with aring of releasable adhesive 864 to secure it to the top of pneumostomavent 204. Adhesive 864 is preferably positioned so as not to contactfilter 248. Pneumostoma plug 860 is also provided with a handle 866and/or tab 868 to facilitate application and removal of pneumostoma plug860. Pneumostoma plug 860 is designed to cover, obstruct and protecthydrophobic filter 248 to prevent material entering or exiting tube 240during use. Unlike the pneumostoma plug 840 of FIGS. 8A-8B, pneumostomaplug 860 does not include a stopple 852. During use of plug 860 of FIGS.8C and 8D, the channel of a pneumostoma 110 will contain the tube 240 ofpneumostoma vent 204 as shown in FIG. 8D. Pneumostoma plug 860 isnon-porous and may be used to temporarily cover and/or seal apneumostoma vent 204 during brief activities such as e.g. spirometrytesting, showering or working in a dirty environment to prevent entry ofmaterial into the pneumostoma or exit of material from the pneumostoma.Note the pneumostoma plug 860 may be used with a pneumostoma vent 204even where no chest mount 202 is used.

Alternative Features And Embodiments

FIGS. 9A-9H show views of alternative designs of pneumostoma vent. FIG.9A shows an alternative pneumostoma vent 900 which has features withintube 904 designed to encourage migration of discharge (for example mucusand sputum) out of the lung and prevent it from re-entering the lung.These features may include baffles that preferentially allow dischargeto travel along and out of the inner lumen of the tube. As shown in FIG.9A the interior surface of tube 904 is covered with an array of baffles905 which point away from the aperture 906 in the distal end of tube904. Discharge that enters tube 904 through aperture 905 is pushedtowards filter 908 by air flow during exhalation. When the patientinhales, some air may enter through cap 908, however, the Discharge isinhibited from traveling back towards aperture 905 by the shape of thebaffles 905. Thus, discharge is collected in tube 904. The discharge isremoved and disposed of when pneumostoma vent 900 is replaced.

FIG. 9B shows a pneumostoma vent 910 having external features on thesurface of tube 914. External features such as rings or ridges may beutilized on a pneumostoma vent to make a better seal between theexterior of the pneumostoma vent and the interior of the channel of thepneumostoma. FIG. 9B shows a sectional view through two rings 915, 917around the exterior surface of tube 914. These rings engage the channelof the pneumostoma to make a better seal. The rings 915, 917 serve toprevent leakage of mucus and discharge around tube 904. The rings 915,917 also reduce the possibility of the entry of any materials into thepneumostoma other than through filter 918 and aperture 916.

FIG. 9C shows an alternative pneumostoma vent 920 which has a pluralityof side apertures 925 in order to facilitate entry of gases and/ordischarge from a pneumostoma into the lumen of tube 924. Gases may leavetube 924 through filter 928 while discharge is retained within tube 924.One or more side openings 925 may be provided along tube 924 and/orclose to the distal opening 926. The side openings 925 may be providedinstead of, or in addition to, the opening 926 in the end of distal tipof tube 925. The side openings 925 permit gases and/or discharge toenter tube 924 even if one or more openings is occluded by tissue orother matter. Side openings may be provided in any of the pneumostomavent tubes discussed in this application. The tube of a pneumostoma ventsuch as tube 924 may also be created from a porous material such thatair may enter the lumen of the tube through the wall of the tube 924.The porous tube wall may be provided in addition to or instead of thepresence of distal opening 926 or side openings 925. The tube ofpneumostoma vent such as tube 932 may also be provided with features formaintaining the patency of the pneumostoma as shown in U.S. patentapplication Ser. No. 12/030,006 entitled “Variable Parietal/VisceralPleural Coupling” which is incorporated herein by reference.

FIG. 9D shows an alternative pneumostoma vent 930 which has featureswithin tube 934 designed to absorb discharge and prevent it fromre-entering the lung. As shown in FIG. 9D, tube 934 includes a layer ofabsorbent material 935 within the wall of tube 934. The absorbentmaterial 935 is exposed where the tube 934 is penetrated by sideopenings 937 Discharge that enters tube 934 through side openings 937 isabsorbed by absorbent material 935. Any discharge that enters tube 934though side openings 937 and end opening 936 is retained within tube 934by filter 938 which is mounted flush with flange 932. Thus, discharge iscollected in tube 934. The discharge is removed and disposed of whenpneumostoma vent 930 is replaced.

FIG. 9E shows an alternative pneumostoma vent 940 which has featureswithin tube 944 designed to absorb discharge and prevent it fromre-entering the lung. As shown in FIG. 9E, tube 944 includes a layer ofabsorbent material 945 coated on the inside of tube 944. The absorbentmaterial 945 is exposed on the inside of tube 944 such that dischargethat enters tube 944 through opening 946 is absorbed by absorbentmaterial 945. Any excess discharge that enters tube 944 is retainedwithin tube 944 by filter 948 which is interference fit within flange942. Thus, discharge is collected in tube 944. The discharge is removedand disposed of when pneumostoma vent 940 is replaced.

FIG. 9F shows an alternative pneumostoma vent 950 which has featuresexternal to tube 954 designed to absorb discharge and prevent it fromre-entering the lung. As shown in FIG. 9F, a ring of absorbent material955 is positioned around the proximal end of tube 954 where it meetsflange 952. During use, the absorbent material 955 is trapped betweenflange 952 and the skin of the patient surrounding the pneumostoma.Discharge that leaks from the pneumostoma around the tube 954 isabsorbed by absorbent material 955. Any discharge that enters tube 954is retained within tube 954 by filter 958 which is bonded to the surfaceof flange 952. Thus, discharge is collected in tube 954. The dischargeis removed and disposed of when pneumostoma vent 950 is replaced.

FIG. 9G shows an alternative pneumostoma vent 960 which has featuresincorporated in flange 962 to absorb discharge and prevent it fromre-entering the lung. As shown in FIG. 9G, disc of absorbent material965 is laminated within a flexible flange 962. The flange 962 may be alaminate of polymers with an absorbent material in the middle which isflexible enough to conform to the chest of a patient. The flange 962 maybe 3 mm or less in thickness and more preferably approximately 1 mm orless in thickness. The disc of absorbent material 965 is exposed aroundthe proximal end of tube 964 where it meets flange 962. During use, theabsorbent material 965 is exposed to the opening of the pneumostoma.Discharge that leaks from the pneumostoma around the tube 964 isabsorbed by absorbent material 965. Any discharge that enters tube 964is retained within tube 964 by filter 968. Filter 968 is attached to theproximal end of tube 964 by a plug 969. Plug 969 may be welded, bondedwith adhesive or otherwise secured to tube 964 and/or flange 962 andoperates in combination with flexible flange 962 to limit insertion oftube 964 into a pneumostoma. Thus, discharge is collected in tube 964and flange 962. The discharge is removed and disposed of whenpneumostoma vent 960 is replaced.

FIG. 9H shows an alternative pneumostoma management system 970 which hasfeatures incorporated in a chest mount 972 to absorb discharge andprevent it from re-entering the lung. As shown in FIG. 9H, a disc ofabsorbent material 975 is laminated within a flexible chest mount 972.The chest mount 972 may be a laminate of polymers with an absorbentmaterial in the middle which is flexible enough to conform to the chestof a patient. The chest mount 972 may be 3 mm or less in thickness andmore preferably approximately 1 mm or less in thickness. The disc ofabsorbent material 975 is exposed around the proximal end of tube 974 ofpneumostoma vent 971 where it passes through chest mount 972. Duringuse, the absorbent material 975 is exposed to the opening of thepneumostoma. Discharge that leaks from the pneumostoma around the tube974 is absorbed by absorbent material 975. Any discharge that enterstube 974 is retained within tube 974 by filter 978. Filter 978 isattached to the proximal end of tube 974 as described elsewhere. Thus,discharge is collected in tube 974 and chest mount 972. The discharge isremoved and disposed of when pneumostoma vent 971 and chest mount 972 isreplaced. One or more features to control and/or absorb dischargeemanating from the pneumostoma, for example those features shown inFIGS. 9A-9F may be incorporated into pneumostoma vents and chest mountsof different design—for example those other pneumostoma vent designsdescribed elsewhere in this application.

FIGS. 10A-D illustrate alternative configurations of adhesive on thedistal surface 1032 of a pneumostoma vent 1000. Flange 1002 ofpneumostoma vent 1000 has an adhesive material distributed thereon. Inthe absence of a chest mount, this adhesive is used to temporarilysecure the flange 1002 of the pneumostoma vent 1000 to the chest of thepatient. Adhesive materials may be hydrocolloid adhesives which absorbmoisture while retaining good adhesiveness. However, even the bestadhesives may cause irritation of the skin during prolonged exposure.Tissue irritation may result from merely from build up of moisture onthe skin behind the pneumostoma vent 1000 regardless of the presence ofany particular adhesive. However, the distribution of adhesive may becontrolled so as to help reduce irritation to the skin of the patient.

One way to reduce the potential for irritation is by reducing the amountof time any particular portion of skin is in contact with adhesiveand/or allowing the skin in regions behind pneumostoma vent 1000 to“breathe” when not in contact with adhesive. Thus, in some embodimentsthe adhesive may be provided in stripes or patches and absent in otherstripes or patches. The adhesive areas may also be elevated slightlyabove the surface of flange 1002 such that non adhesive areas of flange1002 do not contact the skin but leave a slight air gap through whichair may circulate and/or moisture may escape. The adhesive patchesthemselves may comprise a breathable laminate and adhesive so that theprolonged attachment of the PMD does not irritate the skin. The adhesivepatches may be arranged differently on different chest mounts so as tocontact different regions of skin surrounding a pneumostoma.Alternatively the arrangement of adhesive patches may be the same oneach chest mount but the registration of the patches may be changed bychance or deliberately each time a chest mount is replaced so that theadhesive patches contact different regions of skin surrounding apneumostoma.

Referring now to FIG. 10A where the contact surface 1032 of a flange1002 of a pneumostoma vent 1020 is shown. Adhesive pads 1034, 1035 arelocated on contact surface 1032 around tube 1004. The adhesive isselected so as to help maintain the correct position of pneumostoma vent1020 without causing undue irritation to the skin of the patient. Asshown in FIG. 10A, adhesive pads 1034, 1035 are provided in two discretespaced-apart regions. Each adhesive pad 1034, 1035 preferably comprisesa laminate structure with an inner plastic, paper or foam layer (e.g.,closed-cell polyethylene foam) sandwiched between layers of adhesive.The adhesive pads 1034, 1035 are elevated above contact surface 1032 bythe thickness of the inner layer. Thus, only some portions of skinaround a pneumostoma will be in contact with adhesive each timepneumostoma vent 1000 is changed. Different pneumostoma vents may beprovided with different arrangements of adhesive patches. For example asecond pneumostoma vent may have adhesive patches located in the emptyareas 1036, 1037 of contact surface 1032 such that it will contactdifferent areas of skin.

FIG. 10B shows a sectional view of pneumostoma vent 1020 along line B-B.FIG. 10B shows that contact surface 1032 is spaced apart from the skinof the patient when pneumostoma vent 1000 is applied. Air can circulatebetween the adhesive pads 1034, 1035. As previously described, theadhesive pads may be protected by a protector sheet that is removedprior to use of PMD 200. The pneumostoma vent 1000 is also provided withone or more tabs 1016 which are free of adhesive. These tabs 1016 allowa patient to grip the flange 1002 to gently peel the chest mount off theskin when it needs replacement.

Adhesive pads 1034, 1035 may alternatively be rings of hydrocolloidadhesive of approximately a millimeter in thickness and secured toflange 1002 with a transfer adhesive. Any medically approved waterresistant pressure sensitive adhesive may be used to attach thepneumostoma vent to the skin of the patient, such as hydrocolloidadhesives, zinc oxide adhesives and hydrogel adhesives. Particularlyeffective adhesives in providing the desired adhesive properties tosecure the pneumostoma vent to the skin of the wearer without irritationare formed from cross-linking polymers with a plasticizer to form a3-dimensional matrix. Some useful adhesives are disclosed in WO00/07637, WO 00/45866 WO 00/45766 and U.S. Pat. No. 5,543,151 which areincorporated herein by reference. The adhesive can be applied to thecontact surface 1032 of flange 1002 by any means known in the art, forexample slot coating, spiral, or bead application or printing.

Referring now to FIG. 10C where a different distribution of adhesive oncontact surface 1042 of flange 1041 of a pneumostoma vent 1040 is shown.As shown in FIG. 10C, adhesive pads may be distributed in small patches1042. The adhesive patches 1044 may cover a less than 100% of thecontact area 1042. As shown in FIG. 10C, adhesive patches 1044 coverapproximately half of the contact surface 1042 of pneumostoma vent 1040.Adhesive patches 1044 preferably cover from 10% to 50% of contactsurface 1042. With the distribution pattern of FIG. 10C all pneumostomavents may have the same distribution of adhesive. Because patches 1044are small and evenly distributed, variations of the orientation ofplacement of pneumostoma vent 1040 will randomize the location of thepatches 1044 relative to the skin of the patient such that a particularregion of skin is only in contact with adhesive for a percentage of timesimilar to the percentage of coverage.

FIG. 10D illustrates an alternative method for rotating the portions ofskin around a pneumostoma that are in contact with adhesive. As shown inFIG. 10D, pneumostoma vent 1050 has eight radial adhesive patches 1052.The patches are arranged in a regular pattern around tube 1058 such thatthe patches are interspersed with non-adhesive areas 1056. As shown inFIG. 10D, adhesive patches 1054 cover approximately half of the contactsurface 1052 of pneumostoma vent 1050. Adhesive patches 1054 preferablycover from 10% to 50% of contact surface 1052. A tab 1057 is alignedwith one of the adhesive patches 1054. With the pneumostoma vent 1050 ofFIG. 10D, the patient deliberately changes the orientation of tab 1057relative to the pneumostoma each time a pneumostoma vent 1050 ischanged. By changing the rotation of the pneumostoma vent 1050 thepatient can change which portions of skin are in contact with adhesivepatches 1054. The adhesive distribution pattern of FIG. 10D is alsoadvantageous because air can circulate between adhesive patches 1054.The circulation of air allows moist air to exit from between the skin ofthe patient and flange 1051.

FIGS. 10E-10G illustrate an alternate pneumostoma vent 1060. As shown inFIG. 10E, pneumostoma vent 1060 has a flexible connector 1061 connectingflange 1062 and tube 1064. As illustrated in FIG. 10E, flexibleconnector 1061 may be formed in one piece with flange 1062 and tube1061. An accordion or bellows-like flexible connector 1061 is shown. Inalternative embodiments connector 1061 may be a separatejoint/coupling/component or a region of flexible material. For example,a lower durometer material having more flexibility to allow bending butalso having a wire reinforcement to prevent radial tube collapse.Flexible connector should be flexible enough to allow relative movementof flange 1062 and tube 1064 while providing sufficient stability toallow insertion of tube 1064 into a pneumostoma. Additionally, theconnector should be selected so as not to prevent gases from escapingthrough the lumen of tube 1064. In alternative embodiments the flexibleconnector 1061 may form part of flange 1062 instead of tube 1064.

As shown in FIG. 10F, in some embodiments, flexible connector 1061 maybe sufficiently flexible to allow flange 1062 to fold parallel to tube1064. This is advantageous in that it reduces the size of packagingrequired to contain pneumostoma vent 1060. In many cases, a patient willchange their pneumostoma vent daily. Thus, the space occupied by onemonth's supply of pneumostoma vents becomes considerable. By folding theflange 1062 parallel with the tube 1064, the overall packaging volume(height*length*width) for the pneumostoma vent 1060 can be significantlyreduced. The reduction in volume weight and amount of packing increasesthe convenience to the patient. Additionally, the reduction in volumeand packing materials required reduces associated shipping costs andexpense.

As shown in FIG. 10G, a flexible connector 1061 may also be useful tofacilitate insertion of tube 1064 into a pneumostoma 1068 which isoriented at an angle relative to the skin 114 of the patient. Apneumostoma 1068 may be formed at an angle during the pneumostomyprocedure or may migrate slightly over time. The angle formed betweenthe skin 114 of the chest 100 and the pneumostoma 1068 will depend notonly upon the pneumostomy procedure but also the location of thepneumostoma and the patient's anatomy in the region of the pneumostoma1068. If the flange 1062 is inflexibly mounted to the tube 1064, it willtend to pull up on one side of the pneumostoma and “dig in” on the otherside of the pneumostoma—destabilizing the pneumostoma vent and causingthe patient discomfort.

As shown in FIG. 10G, flexible connector 1061 is advantageous in that itallows flange 1062 to lay flat against the skin 114 of chest 100 whileallowing tube 1064 to follow the channel of pneumostoma 1068. Theflexible connector 1061 allows the pneumostoma vent 1060 to conform tothe pneumostomas of a wide range of patients. Note that flexibleconnector is designed so as to allow variation in the relative angle offlange 1062 and tube 1064 without greatly impinging upon the lumen oftube 1064. However, for this application it is not essential thatflexible connector permit flange 1062 and tube 1064 to be parallel toone another as the pneumostoma will more typically be oriented withinforty-five degrees of perpendicular to the skin 114 of chest 100.

FIG. 10H illustrates an alternate pneumostoma vent 1070. As shown inFIG. 10H, pneumostoma vent 1070 has a flexible connector 1071 connectingflange 1072 and tube 1074. An accordion or bellows-like flexibleconnector 1071 is shown. As illustrated in FIG. 10H, flexible connector1071 may be formed in one piece with flange 1072 and/or tube 1071.Flexible may alternatively be formed separately from flange 1072 and/ortube 1071 and securely attached to flange 1072 and/or tube 1071.Flexible connector 1071 may expand or contract in length therebyallowing adjustment to the length of pneumostoma vent 1070. The lengthof pneumostoma vent 1070 may be manually adjusted by stretching orcompressing flexible connector 1071. The length of pneumostoma vent 1070may be manually adjusted to suit a particular patient prior to insertionof tube 1074 into a pneumostoma. Additionally flexible connector 1071may bend during insertion to facilitate insertion of tube 1074 into apneumostoma which is oriented at an angle relative to the skin 114 ofthe patient. Additionally flexible connector 1071 may expand or contractin vivo thereby allowing the length of pneumostoma vent 1070 to adjustand accommodate movement of the pneumostoma as the patient moves.Additionally, flexible connector 1071 may be sufficiently flexible toallow flange 1072 to fold parallel to tube 1074 prior to use for reducedpackaging volume.

FIG. 10I illustrates an alternate pneumostoma vent 1080. As shown inFIG. 10I, pneumostoma vent 1080 has a spring 1081 an inner tube 1085 andouter tube 1084. Inner tube 1085 is connected to flange 1082. Spring1081 is a polymer or metal spring and is preferably bonded at theproximal end inner tube 1085 and at the distal end to outer tube 1084.Spring 1081 may be a coil spring as shown or a leaf spring, or otherelastic element. As shown outer tube 1084 is received over inner tube1085 and can slide so that the overall length of pneumostoma vent 1080may increase or decrease by compressing or stretching spring 1081.Spring 1081 may expand or contract in length thereby allowing adjustmentto the length of pneumostoma vent 1080. The length of pneumostoma vent1080 may be manually adjusted by stretching or compressing spring 1081.The length of pneumostoma vent 1080 may be manually adjusted to suit aparticular patient prior to insertion of tube 1084 into a pneumostoma.Additionally spring 1081 may expand or contract in vivo thereby allowingthe length of pneumostoma vent 1080 to adjust and accommodate movementof the pneumostoma as the patient moves.

FIG. 10J illustrates an alternate pneumostoma vent 1090. As shown inFIG. 10J, pneumostoma vent 1090 has a flexible connector 1091 formed atthe end of an inner tube 1095. Inner tube 1095 is connected at the otherend to flange 1092. Flexible connector 1091 is preferably formed in onepiece with inner tube 1095 and then bonded at the distal end to outertube 1094. As shown in FIG. 10J, outer tube 1094 is received over innertube 1095 and can slide so that the overall length of pneumostoma vent1090 may increase or decrease by compressing or stretching flexibleconnector 1091. Flexible connector 1091 may expand or contract in lengththereby allowing adjustment to the length of pneumostoma vent 1090. Thelength of pneumostoma vent 1090 may be manually adjusted by stretchingor compressing flexible connector 1091. The length of pneumostoma vent1090 may be manually adjusted to suit a particular patient prior toinsertion of tube 1094 into a pneumostoma. Additionally flexibleconnector 1091 may expand or contract in vivo thereby allowing thelength of pneumostoma vent 1090 to adjust and accommodate movement ofthe pneumostoma as the patient moves.

FIGS. 11A-B show exploded and sectional views of a pneumostomamanagement device comprising pneumostoma vent system 1100. Pneumostomavent system 1100 is designed to be secured directly to the chest of thepatient. FIG. 11A shows an exploded view of the main components ofpneumostoma vent system. From left to right these components are carriersheet 1101, adhesive cover 1102, filter 1104, vent 1106, and adhesivepatch 1109 and washer 1110. Adhesive cover 1102 is a thin porousbiocompatible membrane which is adhesive on the surface facing thepneumostoma (the inner surface see 1126 in FIG. 6B) and non-adhesive onthe outer surface 1120. A suitable material for adhesive cover 1102 is athin polyurethane film bearing an acrylic adhesive—such materials areavailable from 3M of St. Paul, Minn. The film is biocompatible as wellas thin, strong, and breathable. Adhesive cover 1102 has an aperture1103 large enough to allow air to exit through filter 1104. Aperture1103 is preferably slightly smaller than filter 1104 so that annularcover can be used to secure filter 1104 to vent 1106. Exposed portionsof annular adhesive cover 1102 are provided with a paper cover toprotect the adhesive prior to use. Adhesive cover is releasably securedto a carrier liner 1101 for ease of handling during manufacture andapplication of the finished pneumostoma vent system 1100. Carrier liner1101 is removed after the pneumostoma vent system 1100 has beencorrectly positioned in the pneumostoma. The carrier liner 1101 need notcover the entire adhesive cover 1102, but may be star-shaped or anothershape different than the adhesive cover. This allows for ease ofhandling and placing the adhesive cover with reduced likelihood ofcreating bubbles and wrinkles in the adhesive cover during placement.The carrier liner may be arranged, for example, in a windowconfiguration.

Filter 1104 is a circular disc of filter material. Filter 1104 ispreferably a hydrophobic filter material. In a preferred embodiment,filter 1104 is a reticulated open cell polyurethane foam or an open cellpolyurethane or polyester foam or melt blown polyethylene. Exemplaryfilter materials include Delpore® DP2001-10P, Delpore® DP2001-20P, andDelpore® DP2001-30P available from Delstar Technologies, Inc.(Middletown, Del.). Filter 1104 is larger than the proximal aperture1123 in vent 1106 and is positioned over the proximal aperture 1123 tofilter gases moving in and out of the vent 1106. Filter 1104 may besecured to vent 1106 by an adhesive, welding, or other bondingtechnology. In a preferred embodiment, filter 1104 is secured to vent1104 with a ring of pressure sensitive adhesive. Filter 1104 is alsosecured to vent 1106 by adhesive cover 1102 instead of or in addition toother bonding techniques.

Vent 1106 comprises a tube 1120 for entering the pneumostoma. Aspreviously discussed, tube 1120 has an atraumatic tip 1121 and one ormore apertures 1122 in the distal end to allows gases and discharge toenter tube 1120 from a pneumostoma. Tube 1120 has a flange 1124 at theproximal end. Flange 1124 is formed in one piece with tube 1120. Filter1104 is secured over proximal opening 1123 of vent 1106 as described inthe previous paragraph. Vent 1106 may be made of a suitableplastic/thermoplastic polymer/thermoplastic elastomer. For example inone preferred embodiment vent 1106 is made of Pebax® a block copolymerwith suitable mechanical and chemical properties available from Arkema(Colombes, France).

An efficient way to make tube 1120 and flange 1124 is illustrated inFIGS. 11E-11G. The process begins with extruded tube stock. The tubestock is cut to the approximate length required as shown in FIG. 11Ewhich shows a length of extruded tube 1160. Vents may be readilymanufactured in a range of lengths according to this method. Next, theproximal end of the tube 1160 is cut in half parallel to the long axisof the tube to a depth of 20 mm or so. The proximal end of tube 1160 isthus in two sections 1162, 1164. The proximal end of tube 1160 is thenplaced in a heated fixture to form the two wings 1166, 1168 of flange1124. Any excess material is trimmed and the flange 1124 is finished asshown in FIG. 11G. In a preferred embodiment, wings 1166, 1168 extend atleast 0.125 to 0.25 inches from the outer diameter of tube 1160 in orderto secure tube 1160 to the remainder of pneumostoma vent system 1100.Tube 1160 may then be trimmed at the distal end to the exact lengthrequired. The distal end is then tipped using a heated fixture to formthe distal end into the rounded distal tip 1121 of the finished vent1106 as shown in FIG. 11H.

Another way to make vent 2006 is illustrated by pneumostoma vent 1190 ofFIG. 11N. Pneumostoma vent 1190 is made from two pieces. A washer-shapedflange 1192 and a tube 1194. The flange 1192 preferably has an outerdiameter approximately twice the diameter of tube 1194. The aperture1193 of flange 1192 is approximately the same size as the inner diameterof the proximal opening 1195 in tube 1194. Flange 1192 is preferablyheat set to the proximal end of tube 1194 but may also be bonded to tube1194 using adhesive, ultrasonic welding and/or other reliable methods ofsecuring the components. As before, tube 1194 may be cut to length fromextruded stock and then tipped at the distal end 1196 in a heatedfixture either before or after attaching flange 1192 to the proximalend.

Referring again to FIGS. 11A and 11B, adhesive patch 1109 is preferablya biocompatible hydrocolloid material. Adhesive patch 1109 has a centralaperture 1109 which is sized to fit vent 1106. The hydrocolloid materialis provided with a polymer layer and a transitional adhesive on the sidefacing flange 1124 in order to better secure adhesive patch 1109 to theflange and annular cover. Flange 1124 is too large to fit throughaperture 1109. The polymer layer prevents aperture 1109 from deformingsufficiently for the flange 1124 to pass through aperture 1109. Duringassembly, the distal side of flange 1124 may also be bonded to thepolymer layer of adhesive patch 1109 using, for example, pressuresensitive adhesive, UV-cured adhesive or ultrasonic welding. Adhesivepatch 1109 is preferably less than 3 mm thick and is more preferably,approximately 1 mm in thickness. Exposed portions of adhesive patch 1109are provided with a paper cover to protect the hydrocolloid adhesiveprior to use. Washer 1110 slides over vent 1106 and is bonded toadhesive patch 1109 and vent 1106. Adhesive patch 1109 is sandwichedbetween washer 1110 and flange 1124 thereby firmly securing adhesivepatch 1109 to vent 1106.

Pneumostoma vent system 1100 is preferably preassembled when provided tothe patient. FIG. 11B shows a sectional view of pneumostoma vent system1100 as assembled. Note that tube 1120 fits through the middle ofadhesive patch 1109. Note also that flange 1124 is trapped betweenadhesive cover 1102 and adhesive patch 1109. In this embodiment, filter1104 is also secured to vent 1106 by adhesive cover 1102. Exposedadhesive regions of adhesive cover 1102 and adhesive patch 1109 on thepatient side of the pneumostoma vent system 1100 assembly are providedwith protective covers 1105 (for example paper covers) to protect theadhesive during shipping and prior to use. The completed or partiallycompleted pneumostoma vent system 1100 is provided as a sterile productto the patient or caregiver. The protective covers 1105 are peeled offprior to application of the pneumostoma vent system 1100 to thepneumostoma. After the pneumostoma vent is correctly positioned in thepneumostoma, the carrier liner 1101 is also removed.

FIGS. 11C and 11D show exploded and sectional views of an alternatepneumostoma vent system 1130. Pneumostoma vent system 1130 is designedfor use without a chest mount although it could be adapted for use witha chest mount. FIG. 11C shows an exploded view of the main components ofpneumostoma vent system 1130. From right to left these components arecarrier sheet 1131, adhesive cover 1132, filter 1134, vent 1136,adhesive patch 1138 and protective cover 1135. No washer is present inthis embodiment.

Adhesive cover 1132 is a thin porous biocompatible membrane which isadhesive on the surface facing the pneumostoma (the distal surface) andnon-adhesive on the outer surface 1150 (the proximal surface). Adhesivecover 1132 has an aperture 1133 large enough to allow air to exitthrough filter 1134. Aperture 1133 is slightly smaller than filter 1134so that adhesive cover 1132 can be used to secure filter 1134 to vent1136. Cover 1135 protects the exposed adhesive areas of adhesive cover1132 prior to use. Adhesive cover 1132 is releasably secured to acarrier liner 1131 for ease of handling during manufacture andapplication of the finished pneumostoma vent system 1130. Carrier liner1131 is removed after the pneumostoma vent system 1130 has beencorrectly positioned in the pneumostoma.

Vent 1136 comprises a tube 1150 for entering the pneumostoma. Aspreviously discussed, tube 1150 has an atraumatic tip 1151 and one ormore apertures 1152 in the distal end to allows gases and discharge toenter tube 1150 from a pneumostoma. Tube 1150 has a flange 1154 at theproximal end. Flange 1154 is formed in one piece with tube 1150 forexample by using the process described with respect to FIGS. 11E-11H.Filter 1134 is a circular disc of filter material. Filter 1134 ispreferably a hydrophobic filter material. Filter 1134 is larger than theproximal aperture 1153 in pneumostoma vent 1136 and is positioned overthe proximal aperture 1153 of vent 1136 to filter gases moving in andout of the vent 1136 as shown in FIG. 11D. In a preferred embodiment,filter 1134 is secured to vent 1136 with a ring of pressure sensitiveadhesive (not shown). Filter 1134 is also secured to vent 1136 byadhesive cover 1132.

Adhesive patch 1138 is preferably a biocompatible hydrocolloid materialAdhesive patch 1138 has a central aperture 1139 which is sized to fitvent 1136. The hydrocolloid material is provided with a polymer layerand a transitional adhesive on the side facing flange 1154 in order tobetter secure adhesive patch 1138 to the flange and adhesive cover.Flange 1154 is too large to fit through aperture 1139. The polymer layerprevents aperture 1139 from deforming sufficiently for the flange 1154to pass through aperture 1139.

Pneumostoma vent system 1100 is preferably preassembled when provided tothe patient. FIG. 11D shows a sectional view of pneumostoma vent system1130 as assembled. Note that tube 1150 fits through the middle ofadhesive patch 1138. Note also that flange 1154 is trapped betweenadhesive cover 1132 and adhesive patch 1138. In this embodiment, filter1134 is also secured to vent 1136 by adhesive cover 1132. Exposedadhesive regions of adhesive cover 1132 and adhesive patch 1138 on thepatient side of the pneumostoma vent system 1130 assembly are providedwith protective cover 1135 (for example a paper cover which may be inone or more parts) to protect the adhesive during shipping and prior touse. The protective covers 1135 are peeled off prior to application ofthe pneumostoma vent system 1130 to the pneumostoma. After thepneumostoma vent 1136 is correctly positioned in the pneumostoma, thecarrier liner 1131 is also removed.

Pneumostoma vent system 1100 and alternate pneumostoma vent system 1130may be applied to a pneumostoma in the same ways previously described.See, e.g., FIGS. 6C, 7A, 7B and accompanying text. The vent is insertedinto the pneumostoma and the tube of the vent passes through the chestwall into the lung. Gases and discharge may enter the vent of thepneumostoma vent system through the distal aperture. The flange issecured to the skin of the patient by the adhesive patch and adhesivecover. The flange, patch and cover cooperate to secure the vent inposition within the pneumostoma. Discharge may accumulate in the tube ofthe vent during use. Periodically or as needed, the pneumostoma ventsystem is removed, disposed of and replaced. Typically the pneumostomavent system will be replaced daily.

The completed pneumostoma vent system 1100 or 1130 is typically providedas an assembled and sterilized product to the patient or caregiver. Theadhesive patch 1109, 1138 adhesive cover 1102, 1132, carrier liner 1101,1131 and protective cover 1105, 1135 are thin and flexible and thus maybe folded along side the tube 1120, 1150 of vent 1106, 1136 forpackaging and transport. This is advantageous in that it reduces thesize of packaging required to contain pneumostoma vent system 1100,1130. In many cases, a patient will change their pneumostoma vent daily.Thus, the space occupied by one month's supply of pneumostoma ventsbecomes considerable. By folding the outer portion of the pneumostomavent system 1100, 1130 parallel with the tube 1120, 1150, the overallpackaging volume (height*length*width) for the pneumostoma vent 1130 canbe significantly reduced. The reduction in volume weight and amount ofpacking increases the convenience to the patient. Additionally, thereduction in volume and packing required reduces associated shippingcosts and expense.

FIG. 11I shows an example of a pneumostoma vent system 1130 in a foldedconfiguration for shipping and storage. As shown in FIG. 11I, thecarrier liner 1131, adhesive cover 1132, adhesive patch 1138 andprotective cover 1135 are all folded alongside tube 1150 of vent 1136.The pneumostoma a vent system 1130 is unfolded prior to removal ofprotective cover 1135 and application to the patient.

FIG. 11J shows an alternate packaging of pneumostoma vent system 1130.As shown in FIG. 11J, pneumostoma vent system 1130 is packaged with amandrel 1180 and cover 1182. Mandrel 1180 is a disposable structuralelement made of plastic or foam. Mandrel 1180 is positioned in line withtube 1150 of vent 1136. The carrier liner 1131, adhesive cover 1132,adhesive patch 1138 and protective cover 1135 are all folded alongsidemandrel 1180. Mandrel 1180 provides support for the components and agripping point for insertion of tube 1150 into a pneumostoma. Protectivecover 1135 holds the remaining components against mandrel 1180 untilremoved. Cover 1182 is a test-tube shaped plastic molding which protectstube 1150 up until insertion in the pneumostoma thereby helping to keepthe tube 1150 free from contaminants.

To use the pneumostoma vent system 1130 as packaged in FIG. 11J, thepatient grips mandrel 1180 with one hand and removes and discards cover1182 with the other hand exposing tube 1150. This arrangement keeps tube1150 free of contaminants and helps avoid handling of tube 1150 by thepatient/caregiver. The patient then inserts tube 1150 into thepneumostoma 110 as shown in FIG. 11K. The patient then peels ofprotective cover 1135, exposing the adhesive surfaces of adhesive cover1132 and adhesive patch 1138 and releasing them from mandrel 1180 asshown in FIG. 11L. The patient then pushes the adhesive surfaces ofadhesive cover 1132 and adhesive patch 1138 against the skin 114adjacent the pneumostoma 110 and applies pressure to carrier liner 1131to smooth them down. Mandrel 1180 may be removed and discarded at thistime. Carrier liner 1131 facilitates handling of adhesive cover 1132which is designed to be flexible and breathable so as not to irritatethe skin surrounding the pneumostoma. Carrier liner 1131 may now bepeeled away and discarded as shown in FIG. 11M, leaving pneumostoma ventsystem 1130 correctly positioned and deployed with filter 1134 exposed.Tube 1150 is secured by adhesive patch 1138 and adhesive cover 1132which, by sandwiching flange 1154 hold tube 1150 in the desiredposition. Gases may now escape from the pneumostoma via tube 1150 andfilter 1134.

Materials

In preferred embodiments the pneumostoma management device and itscomponents are formed from biocompatible polymers or biocompatiblemetals. A patient will typically wear a pneumostoma management devicefor extended periods and thus the materials, particularly of the tubeentering a pneumostoma, should meet high standards for biocompatibility.In general preferred materials for manufacturing pneumostoma managementdevices are biocompatible thermoplastic elastomers that are readilyutilized in injection molding and extrusion processing. As will beappreciated, other suitable similarly biocompatible thermoplastic orthermoplastic polymer materials can be used without departing from thescope of the invention.

Biocompatible polymers for manufacturing pneumostoma management devicesand components thereof may be selected from the group consisting ofpolyethylenes (HDPE), polyvinyl chloride, polyacrylates (polyethylacrylate and polymethyl acrylate, polymethyl methacrylate,polymethyl-coethyl acrylate, ethylene/ethyl acrylate), polycarbonateurethane (BIONATEG), polysiloxanes (silicones), polytetrafluoroethylene(PTFE, GORE-TEX®, ethylene/chlorotrifluoroethylene copolymer, aliphaticpolyesters, ethylene/tetrafluoroethylene copolymer), polyketones(polyaryletheretherketone, polyetheretherketone,polyetherether-ketoneketone, polyetherketoneetherketoneketonepolyetherketone), polyether block amides (PEBAX, PEBA), polyamides(polyamideimide, PA-11, PA-12, PA-46, PA-66), polyetherimide, polyethersulfone, poly(iso)butylene, polyvinyl chloride, polyvinyl fluoride,polyvinyl alcohol, polyurethane, polybutylene terephthalate,polyphosphazenes, nylon, polypropylene, polybutester, nylon andpolyester, polymer foams (from carbonates, styrene, for example) as wellas the copolymers and blends of the classes listed and/or the class ofthermoplastics and elastomers/thermoplastic elastomers in general.

Pneumostoma management devices may be made of a suitable biocompatibleplastic/thermoplastic/thermoplastic elastomer. For example in onepreferred embodiment the tube is made of Pebax® a block copolymer withsuitable mechanical and chemical properties available from Arkema(Colombes, France). Another suitable material is C-FLEX® thermoplasticelastomer available as extruded tube in a variety of dimensions anddurometers from Saint-Gobain Performance Plastics in Clearwater, Fla.Reference to appropriate polymers that can be used for manufacturingPMDs can be found, for example, in the following documents: PCTPublication WO 02/02158, entitled “Bio-Compatible Polymeric Materials;”PCT Publication WO 02/00275, entitled “Bio-Compatible PolymericMaterials;” and, PCT Publication WO 02/00270, entitled “Bio-CompatiblePolymeric Materials” all of which are incorporated herein by reference.Other suitable materials for the manufacture of the PMD include medicalgrade inorganic materials such stainless steel, titanium, ceramics andcoated materials.

Additionally, the tube of a pneumostoma vent may be treated and/orcoated on the exterior surface to facilitate installation. The tube maybe treated and/or coated to make the tube smoother and/or morelubricious to reduce resistance to installation of the vent tube in thepneumostoma. The polymer of the tube may also be treated and/or coatedto make the surface hydrophilic thereby attracting water molecules as alubricant. If a coating is used it should be selected so to bebiocompatible and not cause irritation of the pneumostoma. Lubriciouscoatings include, for example hydrophilic, Teflon, and Parylene/Paralynefilms/coatings. A lubricious coating may also include a therapeuticagent (see below).

Additionally, the tube of a pneumostoma vent may be designed to delivera pharmaceutically-active substance. For purposes of the presentdisclosure, an “pharmaceutically-active substance” is an activeingredient of vegetable, animal or synthetic origin which is used in asuitable dosage as a therapeutic agent for influencing conditions orfunctions of the body, as a replacement for active ingredients naturallyproduced by the human or animal body and to eliminate or neutralizedisease pathogens or exogenous substances. The release of the substancein the environment of pneumostoma vent has an effect on the course ofhealing and/or counteracts pathological changes in the tissue due to thepresence of pneumostoma vent. In particular, it is desirable in someembodiments to coat or impregnate pneumostoma vent withpharmaceutically-active substances that preserve the patency ofpneumostoma and/or are antimicrobial in nature but that do not undulyirritate the tissues of the pneumostoma. However the pneumostoma ventmay also deliver, be coated with or be impregnated with time-releasetherapeutic agents design to have effects on tissues other than thetissues of the pneumostoma.

In particular cases, suitable pharmaceutically-active substances mayhave an anti-inflammatory and/or antiproliferative and/or spasmolyticand/or endothelium-forming effect, so that the functionality of thepneumostoma is maintained. Suitable pharmaceutically-active substancesinclude: anti-proliferative/antimitotic agents including naturalproducts such as vinca alkaloids (i.e. vinblastine, vincristine, andvinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide,teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin,doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins,plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase whichsystemically metabolizes L-asparagine and deprives cells which do nothave the capacity to synthesize their own asparagine); antiplateletagents such as G(GP) llb/llla inhibitors and vitronectin receptorantagonists; anti-proliferative/antimitotic alkylating agents such asnitrogen mustards (mechlorethamine, cyclophosphamide and analogs,melphalan, chlorambucil), ethylenimines and methylmelamines(hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan,nirtosoureas (carmustine (BCNU) and analogs, streptozocin),trazenes-dacarbazinine (DTIC); anti-proliferative/antimitoticantimetabolites such as folic acid analogs (methotrexate), pyrimidineanalogs (fluorouracil, floxuridine, and cytarabine), purine analogs andrelated inhibitors (mercaptopurine, thioguanine, pentostatin and2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes(cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane,aminoglutethimide; hormones (i.e. estrogen); anti-coagulants (heparin,synthetic heparin salts and other inhibitors of thrombin); fibrinolyticagents (such as tissue plasminogen activator, streptokinase andurokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab;antimigratory; antisecretory (breveldin); anti-inflammatory: such asadrenocortical steroids (cortisol, cortisone, fludrocortisone,prednisone, prednisolone, 6a-methylprednisolone, triamcinolone,betamethasone, and dexamethasone), non-steroidal agents (salicylic acidderivatives i.e. aspirin; para-aminophenol derivatives i.e.acetaminophen; indole and indene acetic acids (inaperturethacin,sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac,and ketorolac), arylpropionic acids (ibuprofen and derivatives),anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids(piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone),nabumetone, gold compounds (auranofin, aurothioglucose, gold sodiumthiomalate); silver & silver compounds (e.g. nano-silver, colloidalsilver) immunosuppressives: (cyclosporine, tacrolimus (FK-506),sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenicagents: vascular endothelial growth factor (VEGF), fibroblast growthfactor (FGF); angiotensin receptor blockers; nitric oxide donors;antisense oligionucleotides and combinations thereof; cell cycleinhibitors, mTOR inhibitors, and growth factor receptor signaltransduction kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMGco-enzyme reductase inhibitors (statins); silver compound and proteaseinhibitors.

In some embodiments, the active pharmaceutical substance to be coatedupon or impregnated in the pneumostoma vent is selected from the groupconsisting of amino acids, anabolics, analgesics and antagonists,anaesthetics, anti-adrenergic agents, anti-asthmatics,anti-atherosclerotics, antibacterials, anticholesterolics,anti-coagulants, antidepressants, antidotes, anti-emetics,anti-epileptic drugs, anti-fibrinolytics, anti-inflammatory agents,antihypertensives, antimetabolites, antimigraine agents, antimycotics,antinauseants, antineoplastics, anti-obesity agents, antiprotozoals,antipsychotics, antirheumatics, antiseptics, antivertigo agents,antivirals, appetite stimulants, bacterial vaccines, bioflavonoids,calcium channel blockers, capillary stabilizing agents, coagulants,corticosteroids, detoxifying agents for cytostatic treatment, diagnosticagents (like contrast media, radiopaque agents and radioisotopes),electrolytes, enzymes, enzyme inhibitors, ferments, ferment inhibitors,gangliosides and ganglioside derivatives, hemostatics, hormones, hormoneantagonists, hypnotics, immunomodulators, immunostimulants,immunosuppressants, minerals, muscle relaxants, neuromodulators,neurotransmitters and neurotrophins, osmotic diuretics,parasympatholytics, para-sympathomimetics, peptides, proteins,psychostimulants, respiratory stimulants, sedatives, serum lipidreducing agents, smooth muscle relaxants, sympatholytics,sympathomimetics, vasodilators, vasoprotectives, vectors for genetherapy, viral vaccines, viruses, vitamins, oligonucleotides andderivatives, saccharides, polysaccharides, glycoproteins, hyaluronicacid, and any excipient that can be used to stabilize a proteinaceoustherapeutic

Hydrophobic filter materials for pneumostoma vents should besufficiently porous to allow air to exit through the filter. In order tofacilitate air flow through the filter a filter material with low toextremely low resistance to air flow is preferred consistent with thestructural and size requirements for the filter. Materials forhydrophobic filters are available commercially and filters can befabricated from any suitable hydrophobic polymer, such astetrafluoroethylene, PTFE, polyolefins, microglass, polyethylene andpolypropylene or a mixture thereof. In preferred examples, thehydrophobic filter is a laminated tetrafluoroethylene e.g. TEFLON®,(E.I. du Pont de Nemours Co.) or GORE-TEX® (W.L. Gore, Inc.) of acontrolled pore size. In other examples the hydrophobic filter maycomprise a felted polypropylene; PTFE/polypropylene filter media or areticulated polyurethane-based open cell foam. In a preferredembodiment, the filter is an open cell polyurethane or polyester foam ormelt blown polyethylene. Exemplary filter materials include Delpore®DP2001-10P, Delpore® DP2001-20P, and Delpore® DP2001-30P available fromDelstar Technologies, Inc. (Middletown, Del.). A filter may additionallycomprise an antimicrobial, an anti-bacterial, and/or an anti-viralmaterial or agent, for example silver.

The foregoing description of preferred embodiments of the presentinvention has been provided for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many embodiments were chosenand described in order to best explain the principles of the inventionand its practical application, thereby enabling others skilled in theart to understand the invention for various embodiments and with variousmodifications that are suited to the particular use contemplated. It isintended that the scope of the invention be defined by the claims andtheir equivalents.

What is claimed is:
 1. A pneumostoma management device adapted to allowgases to exit parenchymal tissue of a lung through a pneumostoma in achest of a patient, wherein the pneumostoma management device comprises;a tube adapted to be inserted into the chest through the pneumostoma,the tube having a lumen, a proximal end and a distal end the distal endof the tube having at least one opening adapted to admit gases from theparenchymal tissue of the lung; a flange connected to the proximal endof the tube such that an opening in the flange connects to the lumen ofthe tube, and the flange projecting a sufficient distance from the tubeto preclude passage of flange into the pneumostoma, the flange beingsufficiently thin and flexible to conform to the chest of the patient;the flange having an adhesive coating adapted to releasably secure theflange to the chest of the patient.
 2. The pneumostoma management deviceof claim 1, further comprising: a chest mount which comprises a patch;the patch being sufficiently thin and flexible to conform to the chestof the patient the patch having an aperture larger in diameter than thetube; the chest mount having a distal surface having an adhesive coatingadapted to releasably secure the chest mount to the chest of thepatient; whereby the chest mount is adapted to be secured to the chestof the patient by the adhesive coating on the distal surface, the tubeis selectively inserted into a pneumostoma through the aperture in thepatch, and the pneumostoma management device is selectively secured tothe chest mount by the adhesive coating on the flange.
 3. Thepneumostoma management device of claim 1, wherein the flange and tubeare formed in one piece.
 4. The pneumostoma management device of claim1, wherein the tube is an extruded tube which is formed separately fromthe flange and then bonded to the flange.
 5. The pneumostoma managementdevice of claim 1, wherein the tube is connected substantially centrallyto the flange.
 6. The pneumostoma management device of claim 1,including a filter wherein the filter is too large to fit through thelumen of the tube.
 7. A medical device to allow gases to exit a lungthrough a pneumostoma and from parenchymal tissue of a lung in a chestof a patient, wherein the medical device comprises; a substantiallyplanar flange having a contact surface adapted to contact the chest ofthe patient and an outer surface; the flange being substantially largerin size than a pneumostoma, the flange being sufficiently thin andflexible to conform to the chest; the contact surface having an adhesivecoating adapted so that the flange can be releasably secured to thechest of the patient, the flange having an opening; a tube projectingfrom the flange; and the tube adapted to be inserted into the chestthrough the pneumostoma and into the parenchymal tissue of the lung, thetube having a lumen, a proximal end and a distal end, the distal end ofthe tube having at least one opening adapted to admit gases from theparenchymal tissue of the lung, the proximal end of the tube beingconnected to the flange such that the opening in the flange communicateswith the lumen of the tube.
 8. The medical device of claim 7, furthercomprising: a chest mount which comprises a patch at least as large indiameter as the flange; the patch being sufficiently thin and flexibleto conform to the chest of the patient the patch having an aperturelarger in diameter than the tube; the chest mount having a distalsurface having an adhesive coating adapted to releasably secure thechest mount to the chest of the patient; whereby the chest mount isadapted to be secured to the chest of the patient by the adhesivecoating on the distal surface of the chest mount, the tube isselectively inserted into a pneumostoma through the aperture in thepatch, and the pneumostoma vent is selectively secured to the chestmount by the adhesive coating on the flange.
 9. The medical device ofclaim 7, wherein the flange and tube are formed in one piece.
 10. Themedical device of claim 7, wherein the tube is an extruded tube which isformed separately from the flange and then bonded to the flange.
 11. Themedical device of claim 7, including a filter and wherein the filter istoo large to fit into through the lumen of the tube.
 12. The pneumostomamanagement device of claim 1 wherein: the adhesive coating comprises ahydrocolloid adhesive adapted to releasably secure the flange to thechest of the patient.
 13. The pneumostoma management of claim 1 wherein:the adhesive coating comprises a hydrocolloid adhesive adapted toreleasably secure the flange to the chest of the patient; and ahydrophobic filter disposed over the opening in the flange and securedto one of the flange and tube such that gases passing into and out ofthe lumen of the tube pass through the filter, wherein the filter issubstantially flush with the flange.
 14. The medical device of claim 7wherein: the adhesive coating comprises a hydrocolloid adhesive adaptedto releasably secure the flange to the chest of the patient.
 15. Thepneumostoma management device adapted to allow gases to exit parenchymaltissue of a lung through a pneumostoma in a chest of a patient, whereinthe pneumostoma management device comprises; a tube adapted to beinserted into the chest through the pneumostoma, the tube having alumen, a proximal end and a distal end; the distal end of the tubehaving at least one opening adapted to admit gases from the parenchymaltissue of the lung; wherein the distal end of the tube has an atraumatictip; and a flange connected to the proximal end of the tube such that anopening in the flange connects to the lumen of the tube, the flangeprojecting a sufficient distance from the tube to preclude passage offlange into the pneumostoma, the flange being sufficiently thin andflexible to conform to the chest of the patient; the flange having anadhesive coating adapted to releasably secure the flange to the chest ofthe patient.
 16. The pneumostoma management device of claim 15, whereinthe flange and tube are formed in one piece.
 17. The pneumostomamanagement device of claim 15, wherein the tube is an extruded tubewhich is formed separately from the flange and then bonded to theflange.
 18. The pneumostoma management device of claim 15, wherein thetube is connected substantially centrally to the flange.
 19. Thepneumostoma management device of claim 15 including a filter, whereinthe filter is too large to fit through the lumen of the tube.
 20. Thepneumostoma management device of claim 15 wherein: the adhesive coatingcomprises a hydrocolloid adhesive adapted to releasably secure theflange to the chest of the patient.